Stryker

  • Modèle / numéro de série
    catalog numbers 629503S, 629504S, 629505S, 629506S, 629507S, 629508S, 629509S, 629510S, 629527S, 629537S, 629543S, 629544S, 629545S, 629546S, 629547S, 629548S, 629559S, 629560S, 629561S, 629562S, 629564S, 629566S, 629568S, 629570S
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    VariAx Compression Plating System
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
  • Source
    USFDA

843 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Item No/Model No: 2108-109, 4125-127-090, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090  Lot Code: 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.
  • Description du dispositif
    SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades || Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
  • Manufacturer
  • Modèle / numéro de série
    Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action is limited to I.V. Poles distributed between 01/07/2014 - 06/24/2014.  The following I.V. Pole option numbers come affixed to beds and stretchers:  Manufacturer Model Number and Product Description 2035-112-010; Head End Left, 2 Stage I.V. Pole 2035-113-011; Head End Right, 2 Stage I.V. Pole 0785-035-101; 26", 2 Stage IV Pole Assembly 0785-035-200; 26", 3 Stage IV Pole Assembly 0785-035-300; 30", 3 Stage IV Pole Assembly 0785-035-401; 30", 2 Stage IV Pole Assembly   The following I.V. Pole option numbers ship as service kits.  Manufacturer Service Kit Number and Product Description 1105-035-368; 30" IV POLE 2 STAGE HE PR 1105-035-367; 30" IV POLE 2 STAGE HE PL 1105-035-343; 30" IV POLE 2 STAGE FE PR 1105-035-341; 30" IV POLE, 2 STAGE HE, PR 1105-035-340; 30" IV POLE, 2 STAGE FE, PL 1105-035-338; 30" IV POLE, 2 STAGE FE, PL 1040-035-338; 2-STAGE IV POLEHEAD LT30" ZM 0785-035-340; 2-STAGE IV POLE,HEAD LT, 30" 0785-035-341; 2-STAGE IV POLEHEAD RT 30" 0785-035-343; 2-STAGE IV POLE,FOOT RT, 30" 1105-035-344; 30" IV POLE, 3 STAGE FE, PL 1105-035-342; 30" IV POLE, 3 STAGE HE, PL 1105-035-339; 30" IV POLE, 3 STAGE FE, PR 1105-035-369; 30" IV POLE, 3 STAGE HE, PL 1105-035-366; 30" IV POLE, 3 STAGE HE, PR 0785-035-339; 3-STAGE IV POLE,FOOT RT, 30" 0785-035-342; 3-STAGE IV POLE,HEAD LT, 30" 1105-035-644; 26" IV POLE, 3 STAGE FL 1105-035-642; 26" IV POLE, 3 STAGE HL 1105-035-639; 26" IV POLE 3 STAGE FR 1105-035-637; 26" IV POLE, 3 STAGE HR 0785-035-637; 3-STAGE IV POLE,HEAD RT, 26" 0785-035-639; 3-STAGE IV POLE,FOOT RT, 26" 0785-035-642; 3-STAGE IV POLE,HEAD LT, 26" 1105-035-643; 26" IV POLE, 2 STAGE FR 1105-035-641; 26" IV POLE, 2 STAGE HR 1105-035-640; 26" IV POLE, 2 STAGE FL 1105-035-638; 26" IV POLE, 2 STAGE HL 0785-035-638; 2-STAGE IV POLE,HEAD LT, 26" 0785-035-640; 2-STAGE IV POLE,FOOT LT, 26" 0785-035-641; 2-STAGE IV POLE,HEAD RT, 26" 0785-035-643; 2-STAGE IV POLE,FOOT RT, 26" 2035-112-000; IV POLE - 2 STAGE H/E 2035-113-000; DUAL H/E 2 STAGE IV POLE OPT
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.
  • Description du dispositif
    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. || models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X || and 1125XE.
  • Manufacturer
  • Modèle / numéro de série
    Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
  • Description du dispositif
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
  • Manufacturer
  • Modèle / numéro de série
    Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International , US and US Govt.
  • Description du dispositif
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of || the navigation software and creation of a pathway into the pedicle. The instrument has three || types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The || Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler || tip has been inserted into the pedicle. Next to the navigational information, these depth || indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number--Lot Code: 5511-F-301--ER0215; 5511-F-301--PR04139; 5511-F-301--PR04664; 5511-F-301--PR04862; 5511-F-301--PR04891; 5511-F-301--PR04955; 5511-F-301--PR41122; 5511-F-301--PR4352; 5511-F-301--PR4424; 5511-F-301--PR4425; 5511-F-301--PR4427; 5511-F-301--PR4519; 5511-F-301--PR4734; 5511-F-301--PR4736;  5511-F-302--ER0184; 5511-F-302--PR04795; 5511-F-302--PR04808; 5511-F-302--PR04809; 5511-F-302--PR04810; 5511-F-302--PR04840; 5511-F-302--PR04887; 5511-F-302--PR04902; 5511-F-302--PR4113; 5511-F-302--PR41142; 5511-F-302--PR41143; 5511-F-302--PR4256; 5511-F-302--PR42561; 5511-F-302--PR4429; 5511-F-302--PR4430; 5511-F-302--PR4432; 5511-F-302--PR4520; 5511-F-302--PR4727; 5511-F-302--PR4738; 5511-F-302--PR4739; 5511-F-302--PR4774; 5511-F-302--PRO4626; 5511-F-302--PRO4627; 5511-F-302--PRO4629;  5511-F-401--PR04811; 5511-F-401--PR04848; 5511-F-401--PR04849; 5511-F-401--PR04865; 5511-F-401--PR04866; 5511-F-401--PR04867; 5511-F-401--PR04881; 5511-F-401--PR04882; 5511-F-401--PR4107; 5511-F-401--PR41073; 5511-F-401--PR4115; 5511-F-401--PR4435; 5511-F-401--PR4437; 5511-F-401--PR4718; 5511-F-401--PR4740; 5511-F-401--PR4775; 5511-F-401--PR4779;  5511-F-402--ER0219; 5511-F-402--PR04805; 5511-F-402--PR04805; 5511-F-402--PR04806; 5511-F-402--PR04850; 5511-F-402--PR04851; 5511-F-402--PR04880; 5511-F-402--PR04905; 5511-F-402--PR04906; 5511-F-402--PR4116; 5511-F-402--PR4258; 5511-F-402--PR4440; 5511-F-402--PR4442; 5511-F-402--PR4443; 5511-F-402--PR4716; 5511-F-402--PR4728; 5511-F-402--PR4777;  5511-F-501--ER0217; 5511-F-501--ER0250; 5511-F-501--PR4117; 5511-F-501--PR4118; 5511-F-501--PR4254; 5511-F-501--PR42541; 5511-F-501--PR42593; 5511-F-501--PR4418; 5511-F-501--PR4444; 5511-F-501--PR4445; 5511-F-501--PR4446; 5511-F-501--PR4448; 5511-F-501--PR4449; 5511-F-501--PR4450; 5511-F-501--PR4452; 5511-F-501--PR4524; 5511-F-501--PR4767;  5511-F-502--ER0218; 5511-F-502--PR04884; 5511-F-502--PR04885; 5511-F-502--PR05008; 5511-F-502--PR41191; 5511-F-502--PR41194; 5511-F-502--PR4379; 5511-F-502--PR4456; 5511-F-502--PR4457; 5511-F-502--PR4458; 5511-F-502--PR4459; 5511-F-502--PR4460; 5511-F-502--PR4461; 5511-F-502--PR4525; 5511-F-502--PR4526; 5511-F-502--PR4527; 5511-F-502--PR4768; 5511-F-502--PR4778;  5511-F-601--ER0185; 5511-F-601--ER0280; 5511-F-601--PR04886; 5511-F-601--PR04904; 5511-F-601--PR05021; 5511-F-601--PR05052; 5511-F-601--PR05229; 5511-F-601--PR41421; 5511-F-601--PR41422; 5511-F-601--PR41423; 5511-F-601--PR4464; 5511-F-601--PR4528; 5511-F-601--PR4529; 5511-F-601--PR4752; 5511-F-601--PR4753; 5511-F-601--PR4798; 5511-F-601--PR5026; 5511-F-601--PR5032; 5511-F-601--PR5037; 5511-F-601--PR5046; 5511-F-601--PR5108; 5511-F-601--PR5110;  5511-F-602--ER0186; 5511-F-602--ER0253; 5511-F-602--ER0254; 5511-F-602--ER0265; 5511-F-602--J66915; 5511-F-602--PR04662; 5511-F-602--PR04828; 5511-F-602--PR04863; 5511-F-602--PRO4864; 5511-F-602--PR4099; 5511-F-602--PR42731; 5511-F-602--PR4470; 5511-F-602--PR4471; 5511-F-602--PR4472; 5511-F-602--PR4754; 5511-F-602--PR4757; 5511-F-602--PR4772; 5511-F-602--PR4776; 5511-F-602--PR4781; 5511-F-602--PR4901; 5511-F-602--PR5111; 5511-F-602--PR5112.  Several units of the same lot number are reported in the quantity distributed.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The product is distributed to its branches/agencies and to hospitals nationwide.
  • Description du dispositif
    The Triathlon Posteriorly Stabilized Femoral Component.
  • Manufacturer
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