UPN # LOT # H7493933108200 17245003, 17416605, 17489192 H7493933108350 17245004, 17245005, 17370709, 17408756 H749393310835K1 17411333, 17493554 H7493933110200 17318047 H7493933110350 17275822, 17438003, 17494025, 17501572 H749393311035K1 17328808, 17403871, 17416578, 17459144 H7493933110400 17275824, 17416608 H7493933112350 17245006, 17259580, 17275819 H7493933114350 17275815, 17338207 with Expiration Dates between January 30, 2016 and May 8, 2016

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.

Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits

UPN # LOT #  H7493931006200- 17259582, 17362835, 17501623, 17617274. H7493931008200- 17259557, 17297984, 17362834, 17376747. H7493931010200- 17318044, 17376748, 17459140, 17501573, 17617545.  H7493931012250- 17275816, 17501620, 17575123, 17617353. H7493931014250- 17370708, 17604432, 17624928. H7493931106150- 17259581, 17365684, 17617551. H7493931108150- 17244079, 17404400, 17408751, 17493552, 17647113 H7493931108250- 17245000, 17275820, 17297985, 17297986, 17377401, 17416602, 17433865.  H749393110825K1- 17416577. H7493931108450- 17245001, 17408755, 17411332, 17493550. H7493931110150- 17317825, 17518149. H7493931110250- 17228343, 17259558, 17317546, 17338203, 17365681, 17416573, 17438002, 17518150, 17588842, 17588844, 17621339, 17634403, 17634404, 17639037.  H749393111025K1- 17328810, 17403872, 17416575, 17494061. H7493931110450- 17275823, 17416603, 17459143, 17617552. H7493931112250- 17259584, 17275818, 17338205, 17365682, 17601584, 17613485, 17639463.  H7493931112450- 17245002, 17259556, 17365683, 17416604, 17574538, 17617553.  H7493931114250- 17370706, 17588840, 17625218. H7493931114450- 17275817, 17589950, 17624789. H7493932016300- 17328801, 17352479, 17377392, 17408752, 17501571, 17575124, 17612692, 17613484, 17625883, 17626180, 17626181, 17626182.  H7493932018300- 17377395, 17480649, 17614751, 17617350, 17626183. H7493932024400- 17459142, 17492863. H7493932026400- 17328800, 17353160, 17377393, 17617470, 17624927, 17625216, 17625895.

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution - US Distribution to the states of : CA, LA, FL, WI, NY, IL, MD and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.

Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.

Lot Number: 18876596 Exp Date: February 1, 201 8

Anesthesiology Devices

2

Yes

Nationwide Distribution to AL, CA, MA, and TX.

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm || Material Number: M00576550 || The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

Lot: 17673858

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .

Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 || The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Material Lot/Batch M001761101 9081070 M001761101 9454150 M001761101 11219026 M001761101 11248953 M001761101 11459743 M001761101 11558752 M001761101 12069528 M001761101 12088397 M001761101 12486283 M001761101 12599814 M001761101 12676636 M001761101 12699010 M001761101 12735893 M001761122 8923652 M001761122 8972196 M001761122 9357101 M001761122 9437046 M001761122 9441926 M001761122 11311160 M001761122 11539583 M001761122 12137579 M001761141 8923936 M001761141 9222015 M001761141 9348913 M001761141 9527634 M001761141 11008231 M001761141 11127679 M001761141 11178426 M001761141 11286455 M001761141 11399476 M001761141 12137973 M001761141 12735693 M001761162 9081459 M001761162 9099226 M001761162 9160390 M001761162 9164834 M001761162 9201799 M001761162 9240562 M001761162 9300354 M001761162 9409241 M001761162 11008487 M001761162 11114184 M001761162 11218144 M001761162 11245072 M001761162 11311962 M001761162 11388810 M001761162 11390059 M001761162 11458984 M001761162 11493358 M001761162 11539897 M001761162 11559361 M001761162 12450605 M001761162 12698399 M001761201 9192829 M001761201 9225994 M001761201 9311149 M001761201 9348534 M001761201 9683231 M001761201 11072863 M001761201 11098598 M001761201 11168924 M001761201 11181297 M001761201 11241457 M001761201 11284341 M001761201 11315455 M001761201 11352051 M001761201 11374226 M001761201 11433224 M001761201 11469706 M001761201 11489225 M001761201 11527407 M001761201 11543049 M001761201 11565744 M001761201 12325653 M001761201 12424062 M001761201 12502165 M001761201 12516917 M001761201 12625338 M001761201 12717591 M001761222 8920868 M001761222 8934560 M001761222 9075567 M001761222 9081847 M001761222 9121322 M001761222 9175536 M001761222 9181507 M001761222 9193336 M001761222 9208884 M001761222 9311493 M001761222 9466311 M001761222 9506149 M001761222 9569990 M001761222 11079791 M001761222 11099090 M001761222 11132544 M001761222 11182289 M001761222 11224951 M001761222 11241928 M001761222 11263071 M001761222 11333440 M001761222 11415503 M001761222 11440963 M001761222 # M001761222 11491420 M001761222 11501337 M001761222 11523912 M001761222 12603130 M001761222 12659849 M001761222 12732209 M001761222 12760626 M001761241 9082060 M001761241 9152194 M001761241 9193700 M001761241 9251982 M001761241 9466143 M001761241 9564578 M001761241 11080619 M001761241 11132293 M001761241 11225357 M001761241 11284460 M001761241 11333809 M001761241 11433527 M001761241 11469992 M001761241 12076263 M001761241 12089121 M001761241 12278047 M001761241 12471877 M001761241 12604237 M001761241 12660258 M001761241 12717366 M001761262 8934903 M001761262 8955184 M001761262 8967505 M001761262 9075824 M001761262 9093941 M001761262 9100566 M001761262 9107545 M001761262 9121910 M001761262 9152272 M001761262 9170046 M001761262 9173971 M001761262 9193981 M001761262 9210113 M001761262 9223019 M001761262 9252286 M001761262 9274962 M001761262 9278641 M001761262 9312420 M001761262 9337837 M001761262 9368493 M001761262 9398346 M001761262 9443499 M001761262 9527830 M001761262 9546796 M001761262 9554996 M001761262 9625975 M001761262 9644132 M001761262 9683727 M001761262 9740884 M001761262 11081052 M001761262 11098299 M001761262 11119710 M001761262 11167452 M001761262 11182409 M001761262 11196816 M001761262 11219218 M001761262 11242355 M001761262 11259699 M001761262 11314732 M001761262 11352269 M001761262 11418577 M001761262 11429655 M001761262 11454962 M001761262 11492177 M001761262 11501917 M001761262 11524353 M001761262 11543267 M001761262 11562458 M001761262 12089465 M001761262 12101194 M001761262 12156259 M001761262 12190057 M001761262 12222410 M001761262 12236378 M001761262 12341001 M001761262 12377203 M001761262 12505128 M001761262 12520231 M001761262 12603629 M001761262 12625662 M001761262 12641240 M001761262 12662833 M001761262 12717010 M001761262 12761360 M001761301 8946888 M001761301 9079424 M001761301 9139247 M001761301 9188852 M001761301 9480368 M001761301 9538406 M001761301 9591254 M001761301 9612697 M001761301 9640115 M001761301 9653583 M001761301 9693211 M001761301 9712325 M001761301 9727454 M001761301 9802937 M001761301 11106228 M001761301 11199804 M001761301 11237871 M001761301 11265624 M001761301 11317334 M001761301 11326584 M001761301 11361062 M001761301 11385360 M001761301 11411605 M001761301 11438763 M001761301 11457125 M001761301 11462682 M001761301 11484363 M001761301 11497917 M001761301 11509050 M001761301 11527706 M001761301 11543898 M001761301 12057755 M001761301 12061828 M001761301 12105297 M001761301 12124144 M001761301 12167317 M001761301 12178969 M001761301 12194664 M001761301 12228114 M001761301 12247218 M001761301 12348037 M001761301 12424433 M001761301 12450995 M001761301 12483139 M001761301 12549825 M001761301 12622755 M001761301 12647774 M001761301 12665288 M001761301 12682339 M001761301 12695777 M001761301 12749166 M001761301 12764295 M001761322 8948156 M001761322 8971397 M001761322 9030640 M001761322 9079427 M001761322 9090329 M001761322 9104223 M001761322 9113590 M001761322 9170816 M001761322 9179467 M001761322 9189098 M001761322 9203450 M001761322 9231016 M001761322 9255806 M001761322 9338460 M001761322 9397000 M001761322 9461747 M001761322 9481074 M001761322 9538752 M001761322 9576673 M001761322 9665321 M001761322 9666138 M001761322 9693806 M001761322 9712755 M001761322 9776004 M001761322 11002201 M001761322 11023963 M001761322 11064218 M001761322 11083783 M001761322 11174297 M001761322 11200373 M001761322 11317263 M001761322 11341656 M001761322 11427080 M001761322 11466178 M001761322 11497693 M001761322 11527793 M001761322 11566044 M001761322 12062266 M001761322 12105655 M001761322 12127229 M001761322 12144534 M001761322 12209478 M001761322 12291891 M001761322 12395821 M001761322 12431485 M001761322 12622188 M001761322 12729195 M001761341 9079724 M001761341 9110057 M001761341 9248514 M001761341 9279002 M001761341 9400431 M001761341 9434658 M001761341 9481264 M001761341 9640401 M001761341 9803223 M001761341 9815428 M001761341 11083448 M001761341 11145662 M001761341 11161252 M001761341 11252929 M001761341 11265574 M001761341 11278565 M001761341 11385692 M001761341 11438771 M001761341 11457190 M001761341 11477064 M001761341 11513953 M001761341 11566544 M001761341 12106234 M001761341 12123476 M001761341 12248062 M001761341 12293302 M001761341 12348201 M001761341 12396018 M001761341 12483434 M001761341 12535214 M001761341 12607022 M001761341 12663305 M001761341 12700597 M001761341 12767750 M001761362 8931357 M001761362 8956072 M001761362 9030987 M001761362 9079784 M001761362 9089723 M001761362 9104453 M001761362 9114232 M001761362 9167188 M001761362 9172052 M001761362 9177645 M001761362 9194320 M001761362 9200192 M001761362 9204027 M001761362 9236246 M001761362 9255466 M001761362 9276570 M001761362 9279183 M001761362 9339029 M001761362 9375148 M001761362 9397267 M001761362 9450415 M001761362 9461487 M001761362 9481740 M001761362 9512723 M001761362 9525343 M001761362 9539190 M001761362 9561441 M001761362 9608746 M001761362 9618790 M001761362 9653336 M001761362 9666623 M001761362 9677224 M001761362 9700423 M001761362 9727280 M001761362 9742402 M001761362 9803885 M001761362 9822524 M001761362 11001338 M001761362 11020954 M001761362 11146185 M001761362 11174379 M001761362 11185998 M001761362 11232589 M001761362 11265740 M001761362 11290313 M001761362 11317069 M001761362 11327288 M001761362 11349654 M001761362 11360125 M001761362 11385709 M001761362 11411886 M001761362 11426583 M001761362 11444900 M001761362 11466144 M001761362 11477389 M001761362 11512918 M001761362 11530005 M001761362 11535514 M001761362 11546388 M001761362 11549034 M001761362 11568449 M001761362 12069931 M001761362 12084909 M001761362 12144935 M001761362 12167838 M001761362 12186530 M001761362 12228764 M001761362 12259054 M001761362 12303751 M001761362 12348135 M001761362 12392311 M001761362 12451123 M001761362 12465395 M001761362 12520601 M001761362 12535626 M001761362 12621680 M001761362 12647510 M001761362 12665287 M001761362 12728310 M001761362 12764525 M001761401 8938688 M001761401 9034221 M001761401 9059193 M001761401 9075332 M001761401 9150195 M001761401 9163415 M001761401 9229612 M001761401 9341494 M001761401 9351844 M001761401 9516208 M001761401 9605045 M001761401 9668802 M001761401 9730206 M001761401 9819218 M001761401 11054164 M001761401 11128265 M001761401 11228002 M001761401 11253867 M001761401 11272064 M001761401 11303706 M001761401 11318729 M001761401 11349270 M001761401 11381262 M001761401 11392497 M001761401 11404221 M001761401 11436684 M001761401 11451811 M001761401 11475141 M001761401 11480820 M001761401 11505865 M001761401 11518052 M001761401 11536786 M001761401 12065755 M001761401 12092490 M001761401 12112317 M001761401 12119644 M001761401 12160025 M001761401 12206344 M001761401 12274608 M001761401 12303406 M001761401 12413093 M001761401 12468712 M001761401 12549937 M001761401 12628743 M001761401 12644934 M001761401 12680091 M001761401 12695260 M001761401 12736479 M001761401 12737867 M001761422 8924519 M001761422 8982964 M001761422 9034343 M001761422 9058153 M001761422 9073888 M001761422 9085100 M001761422 9150506 M001761422 9163488 M001761422 9253102 M001761422 9352234 M001761422 9397524 M001761422 9473921 M001761422 9516491 M001761422 9542676 M001761422 9562110 M001761422 9646776 M001761422 9670238 M001761422 9733923 M001761422 9781021 M001761422 9810040 M001761422 9823571 M001761422 11234478 M001761422 11278818 M001761422 11404399 M001761422 11485297 M001761422 11508332 M001761422 11559885 M001761422 12140731 M001761422 12274783 M001761422 12355790 M001761422 12628745 M001761441 8938990 M001761441 9058980 M001761441 9085471 M001761441 9346019 M001761441 9352662 M001761441 9473183 M001761441 9543613 M001761441 9605646 M001761441 9629938 M001761441 9658738 M001761441 9690659 M001761441 9765808 M001761441 9807597 M001761441 11128710 M001761441 11228342 M001761441 11279001 M001761441 11436410 M001761441 11452211 M001761441 11474972 M001761441 11517558 M001761441 11555942 M001761441 12066047 M001761441 12112621 M001761441 12120366 M001761441 12210547 M001761441 12301064 M001761441 12411858 M001761441 12434395 M001761441 12486537 M001761441 12501939 M001761441 12552948 M001761441 12695591 M001761462 8916450 M001761462 8939419 M001761462 8979460 M001761462 9034631 M001761462 9058562 M001761462 9072193 M001761462 9074928 M001761462 9085978 M001761462 9117537 M001761462 9140377 M001761462 9146678 M001761462 9163839 M001761462 9164495 M001761462 9229853 M001761462 9241980 M001761462 9276223 M001761462 9282892 M001761462 9297703 M001761462 9341799 M001761462 9353214 M001761462 9400780 M001761462 9447144 M001761462 9473655 M001761462 9516512 M001761462 9558312 M001761462 9606202 M001761462 9647558 M001761462 9659251 M001761462 9669510 M001761462 9690739 M001761462 9716213 M001761462 9730919 M001761462 9766240 M001761462 9780115 M001761462 9818499 M001761462 11053502 M001761462 11075892 M001761462 11135064 M001761462 11189163 M001761462 11204429 M001761462 11214169 M001761462 11234973 M001761462 11271260 M001761462 11303710 M001761462 11319018 M001761462 11338011 M001761462 11380606 M001761462 11403532 M001761462 11422771 M001761462 11448350 M001761462 11472804 M001761462 11481124 M001761462 11504876 M001761462 11516914 M001761462 11532151 M001761462 11554599 M001761462 12112632 M001761462 12141336 M001761462 12207042 M001761462 12262204 M001761462 12274391 M001761462 12337999 M001761462 12380361 M001761462 12415571 M001761462 12434439 M001761462 12469201 M001761462 12501840 M001761462 12535979 M001761462 12550730 M001761462 12679805 M001761462 12714009 M001761462 12737868 M001761501 9104014 M001761501 9345112 M001761501 9356370 M001761501 12073007 M001761501 12080576 M001761501 12323344 M001761501 12719149 M001761522 9389179 M001761522 9520561 M001761522 9799880 M001761522 11086809 M001761522 11160473 M001761522 11281962 M001761522 11551240 M001761522 12148286 M001761522 12746286 M001761541 9124969 M001761541 9430555 M001761541 9594963 M001761541 11207984 M001761541 11256470 M001761541 11327727 M001761541 11333957 M001761541 11488612 M001761541 11551961 M001761541 12073593 M001761541 12081327 M001761562 8917622 M001761562 8962576 M001761562 9071247 M001761562 9132272 M001761562 9185549 M001761562 9254800 M001761562 9344987 M001761562 9355762 M001761562 9595166 M001761562 9798719 M001761562 11004942 M001761562 11087526 M001761562 11149881 M001761562 11304790 M001761562 11389226 M001761562 11488032 M001761562 11552203 M001761562 12082032 M001761562 12160589 M001761562 12472161

Obstetrical and Gynecological Devices

2

Yes

Worldwide distribution: USA, United Arab Emir., Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Latvia, Libya, Mexico, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Poland, Puerto Rico, Portugal, Russian Fed., Saudi Arabia, Sweden, Slovakia, Tunisia, Turkey, Taiwan, Ukraine, and South Africa.

Boston Scientific, Contour SE Microspheres, for tumor treatment. || UPN Codes: Description: || M001761101 Contour SE/100-300/1mL/2vials || M001761122 Contour SE/100-300/1mL/5vials || M001761141 Contour SE/100-300/2mL/2vials || M001761162 Contour SE/100-300/2mL/5vials || M001761201 Contour SE/300-500/1mL/2vials || M001761222 Contour SE/300-500/1mL/5vials || M001761241 Contour SE/300-500/2mL/2vials || M001761262 Contour SE/300-500/2mL/5vials || M001761301 Contour SE/500-700/1mL/2vials || M001761322 Contour SE/500-700/1mL/5vials || M001761341 Contour SE/500-700/2mL/2vials || M001761362 Contour SE/500-700/2mL/5vials || M001761401 Contour SE/700-900/1mL/2vials || M001761422 Contour SE/700-900/1mL/5vials || M001761441 Contour SE/700-900/2mL/2vials || M001761462 Contour SE/700-900/2mL/5vials || M001761501 Contour SE/900-1200/1mL/2vials || M001761522 Contour SE/900-1200/1mL/5vials || M001761541 Contour SE/900-1200/2mL/2vials || M001761562 Contour SE/900-1200/2mL/5vials

13122098, 13133678, 13139309, 13144163, 13150255, 13157375, 13164676, 13169430, 13172078, 13180899, 13197546, 13213768, 13220736, 13233454, 13251259, 13262950, 13278674, 13291033, 13293589, 13301698, 13306620, 13317116, 13326762, 13329148, 13332362

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13132880, 13142201, 13143356, 13143796, 13146820, 13153528, 13157508, 13165567, 13166306, 13169774, 13185696, 13186362, 13191710, 13200597, 13207924, 13217669, 13218935, 13227088, 13229799, 13234431, 13246627, 13258629, 13260101, 13263374, 13273999, 13285644, 13294293, 13300613, 13304567, 13310993, 13316305, 13320676, 13330228, 13331583

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13130923, 13147139, 13155258, 13172079, 13178809, 13191065, 13192581, 13200707, 13207118, 13210374, 13218941, 13231809, 13248449, 13254037, 13263744, 13271644, 13279829, 13282008, 13327106

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13133460, 13154362, 13168576, 13175013, 13184394, 13199044, 13214124, 13230441, 13251823, 13266469, 13291034, 13303478, 13313446, 13328734

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13132190, 13157130, 13187919, 13226335, 13250499, 13281255

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13127492, 13188449, 13198517, 13215725, 13241693, 13268177, 13290840, 13302012, 13312896

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13129052, 13136527, 13148927, 13152353, 13165576, 13174355, 13175965, 13181718, 13194146, 13208597, 13224138, 13237836, 13247858, 13254934, 13271239, 13272523, 13278365, 13286079, 13301029, 13319652, 13321957, 13333430

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13078764, 13125342, 13137491, 13171350, 13184389, 13201388, 13209951, 13235129, 13258630, 13289326, 13297516, 13312893, 13316315, 13334405

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13138753, 13206659, 13242083, 13263971, 13303899, 13320064

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13203851, 13238594, 13266169

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13126729, 13142903, 13194255, 13203889, 13218136, 13246629, 13268286, 13282925, 13297734, 13309514, 13333432

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13126265, 13134127, 13156455, 13197956, 13204778, 13221991, 13237544, 13254937, 13257431, 13265291, 13284617, 13287900, 13294576, 13295957, 13305078, 13325445, 13325900

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13129051, 13135901, 13149225, 13157131, 13182469, 13188938, 13197790, 13205415, 13221830, 13227176, 13235130, 13268760, 13274658, 13287741, 13298813, 13304261, 13313988, 13331582

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13130319, 13152012, 13194906, 13203641, 13223728, 13265646, 13298652, 13310506, 13329668

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13200352, 13240383

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13135723, 13168839, 13231287, 13322992

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13240906, 13282484

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13149648,13260102

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13284754

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

13250878

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.