195 results
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25ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
FDA Recall
Terminated
·BD Biosciences·Product code GKI·October 2, 2007
Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
FDA Recall
Terminated
·Cyberkinetics Neurotechnology Systems, Inc.·Product code GZL·February 4, 2009
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·June 30, 2015
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Recall
Terminated
·Pentax Medical Company·Product code KOG·July 17, 2014
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
FDA Recall
Terminated
·GVI Technology Partners·Product code IYX·January 16, 2004
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Recall
Terminated
·Gsi Group Inc·Product code DSF·December 2, 2015
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GAS·May 3, 2013
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·August 31, 2015
BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
FDA Recall
Terminated
·Biocare Medical Llc·Product code NJT·March 13, 2012
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code JWH·September 21, 2020
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
FDA Recall
Terminated
·Pentax Medical Company·Product code FCX·September 16, 2013
Revanesse Versa, PN40081
FDA Recall
Terminated
·Prollenium Medical Technologies Inc.
138 Industrial Pky N
Aurora Canada·Product code LMH·November 15, 2018
Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code GDY·January 25, 2010
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·March 20, 2014
Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP EVAC w/O.P. Adapter Component Kit, to be used with OrthoPAT post op suction set, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2696-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GCY·February 25, 2011
American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code GDY·March 31, 2016