• Modèle / numéro de série
    lot Number:  0000080610
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
  • Description du dispositif
    6F ZUMA MAC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: ZM6MAC40A
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic, Inc., 35 -37A Cherry Hill Dr, Danvers MA 01923-2565
  • Source
    USFDA

829 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Custom packs with catalogue# / lot #:  3608/7626621, CB2E25R7/7760483, CB2E28R/7760491, CB4Q86R/7226272, 9156R2/8105907, 1D41R10/7372026, 1F61R4 / 7038360, 1E04R7 / 7277651, 9156R2 / 8105907, 1X37R / 7760774, 3608 / 7626621, 0X01R7 / 7278478,  2567R41/ 6577695, 1E97R2 / 7828564, 5G01R / 7734883, CB5305R1 / 7346602, CB4Q86R / 7226272,  2T10R1 / 7252235, 1D91R1 / 7843300, 1A45R3 /7584969, 3M16R5 / 7411494, CB2J35R3 / 7352341,  CB3R62R / 7668062, 4V60R / 7934463, DLP2X90R /7504957, 3608 /7626621, 3608/ 7626621, 3C86R9/ 7656387,  3608/ 7626621, 3608/ 7626621, HY2K51R14/ 7438662, 2H08R2/ 7668273, 3608/ 7626621, 1A05R15/ 7038597, CB4826R3 / 7843481, 3608/ 7626621, TL4K84R7/ 7900108, CB3K45R6/ 7626276, 9295R2/ 7934447, 2100R3/ 7694869, CB3U51R7 / 7695001, 9156R2/ 8105907, 9182R3/ 7694914, 0M14R12/ 7694762, 2C50R/ 7760791, 3608/ 7626621, 2K98R1/ 7668290, CB0U83R11/ 7721206,  2997R27/ 7438443, 9156R2/ 8105907, TL3E97R5/ 7722225, TL4J32R8/ 7761048, 2Z75R5/ 7960821, CB2E25R7 /7760483, 4W91R/ 7843431, 3608/ 7626621, 9156R2/ 8105907, 1G69R7/ 7760715, 3608/ 7626621, 2T28R1/ 7899872, 9156R2/ 8105907, 1F77R3/ 7722348, 1F77R3/ 7722348, 1F77R3/ 7722348, DLP4X54R/ 7761021, 3608/ 7626621, 3608/ 7626621
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. || Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.
  • Manufacturer
  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide-USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of HONG KONG, JAPAN, AUSTRALIA, CANADA, BELGIUM, CROATIA, AUSTRIA, CYPRUS, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN, ICELAND, IRELAND, ITALY, JORDAN, KWAIT, LEBANON, MALTA, The NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAN MARINO, SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, The UNITED KINGDOM, CHILE, VENEZUELA, BRAZIL, and MEXICO.
  • Description du dispositif
    Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)
  • Manufacturer
  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of HONG KONG, AUSTRALIA, CANADA, AUSTRIA, BELGIUM, CROATIA, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, IRAN, ICELAND, IRELAND, ITALY, THE NETHERLANDS, NORWAY, POTUGAL, SAN MARINO, SAUDI ARABIA, SPAIN, SWEDEN, SWITERLAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, IRAQ, BRAZIL, and MEXICO.
  • Description du dispositif
    Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)
  • Manufacturer
  • Modèle / numéro de série
    See codes for all models in associated Recall Z-0950-2008
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide-USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of HONG KONG, JAPAN, AUSTRALIA, CANADA, BELGIUM, CROATIA, AUSTRIA, CYPRUS, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN, ICELAND, IRELAND, ITALY, JORDAN, KWAIT, LEBANON, MALTA, The NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAN MARINO, SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, The UNITED KINGDOM, CHILE, VENEZUELA, BRAZIL, and MEXICO.
  • Description du dispositif
    Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)
  • Manufacturer
  • Modèle / numéro de série
    Lot No.: 0203951576, 0203961984, 0203967623, 0203968380, 0203972121, 0203975643, 0203975644, 0203977013, 0203986903, 0203986904, 0203986905, 0203986906, 0203986907, 0203986908, 0203987226, 0203987613, 0203987614, 0203987927, 0203992275, 0203994418, 0204000009, 0204008277, 0204013891, 0204013892, 0204013893, 0204021022, 0204025158, 0204032708, 0204036999, 0204077467, 0204086950, 0204086951, 0204086952, 0204086953, 0204093420, 0204100469, 0204100472, 0204106116, 0204127318, 0204128817, 0204133515, 0204133516, 0204133517, 0204133545, 0204133546, 0204133547, 0204135762, 0204135763, 0204150859, 0204151516, 0204151517, 0204152813, 0204153722, 0204164696, 0204168597, N258157001, N258157002, N258157003, N258157004, N258157005, N258158001, N258158002, N258158003, N258158004, N258158005, N258158006, N258158007, N258158008, N258158009, N258158010, N258158011, N258158012, N258158013, N258158014, N258158015, N258162001, N258162002, N258162003, N258162004, N258162005, N258162006, N258162007, N258162008, N258162009, N258162010, N258163001, N258163002, N258163003, N258163004, N258163005, N258320001, N258320002, N258320003, N258320004, N258320005, N258327001, N258327002, N258327003, N258327004, N258327005, N258327006, N258327007, N258327008, N258327009, N258327010, N258327011, N258327012, N258327013, N258327014, N258327015, N258329001, N258329002, N258329003, N258329004, N258329005, N258329006, N258329007, N258329008, N258329009, N258329010, N258329011, N258329012, N258329013, N258329014, N258329015, N258329016, N258329017, N258329018, N258329019, N258329020, N258330001, N258330002, N258330003, N258330004, N258330005, N258981001, N258981002, N258981003, N258981004, N258981005, N258981006, N258981007, N258981008, N258981009, N258981010, N258981011, N258981012, N258981013, N258981014, N258981015, N258985001, N258985002, N258985003, N258985004, N258985005, N258985006, N258985007, N258985008, N258985009, N258985010, N258985011, N258985012, N258985013, N258985014, N258985015, N259066001, N259066002, N259066003, N259066004, N259066005, N259425001, N259425002, N259425003, N259425004, N259425005, N259425006, N259425007, N259425008, N259425009, N259425010, N259898001, N259898002, N259898003, N259898004, N259898005, N259898006, N259898007, N259898008, N259898009, N259898010, N259898011, N259900001, N259900002, N259900003, N259900004, N260559001, N260560001, N260560002, N260560003, N260560004, N260560005, N260560006, N260560007, N260560008, N260560009, N260560010, N260560011, N260560012, N260560013, N260560014, N260941001, N260941002, N260941003, N260941004, N260941005, N260946001, N260946002, N260946003, N260946004, N260946005, N260946006, N260946007, N260946008, N260946009, N260946010, N261572001, N261572002, N261572003, N261572004, N261572005, N261572006, N261572007, N261572008, N261572009, N261572010, N261572011, N261572012, N261572013, N261572014, N261572015, N262484001, N262484002, N262484003, N262484004, N262484005, N262484006, N262484007, N262484008, N262484009, N262484010, N262484011, N262484012, N262484013, N262484014, N262484015, N263403001, N263403002, N263403003, N263403004, N263403005, N263403006, N263403007, N263403008, N263403009, N263405001, N263405002, N263405003, N263405004, N263405005, N263405006, N263408001, N263893001, N263893002, N263893003, N263893004, N263893005, N263893006, N263893007, N263893008, N263893009, N263893010, N263893011, N263893012, N263893013, N263893014, N263895001, N263895002, N263895003, N263895004, N263895005, N263895006, N263895007, N263895008, N263895009, N263895010, N263895011, N263895012, N263895013, N263895014, N263895015, N264167001, N264167002, N264167003, N264167004, N264167005, N264167006, N264167007, N264167008, N264167009, N264167010, N264167011, N264167012, N264167013, N264167014, N264167015, N265426001, N265426002, N265426003, N265426004, N265426005, N265426006, N265426007, N265426008, N265426009, N265426010, N265426011, N265426012, N265426013, N265426014, N265426015, N265429001, N265429002, N265429003, N265429004, N265429005, N265429006, N265429007, N265429008, N265429009, N265429010, N265429011, N265429012, N265429013, N265429014, N265429015, N265940001, N265940002, N265940003, N265940004, N265940005, N265940006, N265940007, N265940008, N265940009, N265940010, N268412001, N268412002, N268412003, N268412004, N268412005, N268415001, N268415002, N268415003, N268415004, N268415005, N268415006, N268415007, N268415008, N268415009, N268415010, N268415011, N268415012, N268415013, N268415014, N268415015, N268416001, N268416002, N268416003, N268416004, N268416005, N268416006, N268416007, N268416008, N268416009, N268416010, N268416011, N268416012, N268416013, N268416014, N268416015, N268417001, N268417002, N268417003, N268417004, N268417005, N268417006, N268417007, N268417008, N268417009, N268417010, N268417011, N268417012, N268417013, N268417014, N268417015, N268419001, N268419002, N268419003, N268419004, N268419005, N268424001, N268424002, N268424003, N268424004, N268424005, N268424006, N268424007, N268424008, N268424009, N268424010.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AL, CA, CO, CT, FL, GA, HI, ID. IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, WY. OUS to include: Argentina, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, San Marino, Jordan, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.
  • Description du dispositif
    Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Medtronic Model 8598A Spinal Segment Revision Kit is used when a revision to the spinal segment of a Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port. || To deliver parenteral drugs to the intrathecal space. The needle is used to facilitate the placement of the catheter. The needle is inserted percutaneously into the intrathecal. The needle stylet is then removed to confirm the needle placement through observing backflow of cerebrospinal fluid (CSF) through the needle. The needle stylet prevents tissue coring and also minimizes loss of CSF. The spinal segment tip of the catheter is inserted through the needle until the catheter is advanced to the desired location. Once the catheter position is verified through fluoroscopy, the needle is carefully removed and discarded.
  • Manufacturer
824 en plus