ClearanceBrief
Panels › Gastroenterology, Urology › Product code FGE · Class 2

Stents, Drains And Dilators For The Biliary Ducts

Regulation 876.5010

10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
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Top companies in FGE

Company510(k)sRecalls
Boston Scientific5681
Ev3 Corporation1271
Bard Peripheral Vascular, Inc.269
Edwards Lifesciences, LLC752
Cordis Corp.3814
Cook Medical Incorporated039
Cook Incorporated2213
Wilson-Cook Medical, Inc.2015
Hobbs Medical, Inc.321
Guidant Corp.200
Decided510(k)Device and applicantCode
Sep 23, 1991K912122CHOLANGIOGRAPHY CATHETER
Wiltek Medical, Inc.
FGE
Sep 13, 1991K912971INTHERM RADIALLY EXPANDING DILATER
Interventional Therapeutics Corp.
FGE
Aug 20, 1991K900205DRAINAGE CATHETERS W/A DISSOLVABLE TIP
Boston Scientific Corp
FGE
Jun 4, 1991K911581PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
Johnson & Johnson Interventional Systems
FGE
May 10, 1991K910671MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
Solos Endoscopy, Inc.
FGE
May 1, 1991K911292SCHNEIDER WALLSTENT(R)
Pfizer Hospital Products Group, Inc.
FGE
Apr 8, 1991K910219LAPAROMED CHOLANGIOGRAM DEVICE
Laparomed Corp.
FGE
Apr 2, 1991K910931BILIARY BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Mar 28, 1991K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETER
Applied Vascular Devices, Inc.
FGE
Mar 21, 1991K905738OPERATIVE CHOLANGIOGRAPHIC CATHETER
Applied Vascular Devices, Inc.
FGE
Mar 19, 1991K910768SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
Surgitek Medical Engineering Corp.
FGE
Mar 15, 1991K904669BALLOON CATHETERS
Olympus Corp.
FGE
Feb 13, 1991K910006AVD INTIMAX (TM) BILIARY CATHETER
Applied Vascular
FGE
Feb 13, 1991K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
Baxter Healthcare Corp
FGE
Feb 1, 1991K905714ERCP CANNULA
Everest Medical Corp.
FGE
Jan 18, 1991K905229LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
Arrow Intl., Inc.
FGE
Oct 26, 1990K900923ZIMMON ENDOSCOPIC PANCREATIC STENT
Wilson-Cook Medical, Inc.
FGE
Oct 22, 1990K903420SOEHENDRA STENT RETRIEVER
Wilson-Cook Medical, Inc.
FGE
Oct 10, 1990K903858COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
Cook, Inc.
FGE
Aug 22, 1990K902734PR CANNULAS
Olympus Corp.
FGE
Jul 16, 1990K902107WILSON-COOK SYRINGE HOLDERS
Wilson-Cook Medical, Inc.
FGE
Jun 22, 1990K901582DOBBHOFF BILIARY STENT SET
Biosearch Medical Products, Inc.
FGE
Jun 22, 1990K901427BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
Telemed Systems, Inc.
FGE
Jun 21, 1990K901433SURE-FLEX ANASTOMOTIC BALLOON DILATOR
Telemed Systems, Inc.
FGE
Jun 21, 1990K901432BILIARY BALLOON DILATOR
Telemed Systems, Inc.
FGE
Jun 18, 1990K901431TELEMED ERCP CANNULA
Telemed Systems, Inc.
FGE
May 11, 1990K900904CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
Candela Laser Corp.
FGE
Apr 9, 1990K896323WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
Wilson-Cook Medical, Inc.
FGE
Mar 29, 1990K896391BARD/ANGIOMED STENTS
C.R. Bard, Inc.
FGE
Feb 2, 1990K896518DOBBHOFF(R) ERCP CANNULA
Biosearch Medical Products, Inc.
FGE
Jan 30, 1990K896503PORGES ERCP CATHETERS
Porges Corp.
FGE
Jan 26, 1990K896506PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
Porges Corp.
FGE
Jan 26, 1990K896504PORGES 2-WAY BALLOON EXTRACTION CATHETER
Porges Corp.
FGE
Jan 22, 1990K896423PORGES BILIARY STENTS
Porges Corp.
FGE
Jan 22, 1990K896376PORGES NASOBILIARY DRAIN
Porges Corp.
FGE
Dec 21, 1989K894871WILTEK BILIARY STENT SET
Wiltek Medical, Inc.
FGE
Dec 21, 1989K894867WILTEK E.R.C.P. CATHETER
Wiltek Medical, Inc.
FGE
Dec 8, 1989K896069WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
Wilson-Cook Medical, Inc.
FGE
Dec 1, 1989K896163SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
Schneider Stent
FGE
Sep 29, 1989K884714BILIARY DIALATOR
Primrose Medical, Inc.
FGE
May 4, 1989K892384BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
Porges Corp.
FGE
May 4, 1989K892383BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
Porges Corp.
FGE
May 1, 1989K880343BURNEY GALLBLADDER CATHETER KIT
Mallinckrodt Critical Care
FGE
Apr 21, 1989K882610COOK-GIANTURCO BILIARY Z STENT
Cook, Inc.
FGE
Feb 16, 1989K885180EXPANDABLE BILIARY STENT ENDOPROSTHESIS
Schneider Intl., Ltd.
FGE
Jun 17, 1988K873606MODIFIED COPE SUTURE ANCHOR
Cook, Inc.
FGE
Jan 29, 1988K873954NAMIC HAWKINS UNIVERSAL DRAINAGE SET
North American Instrument Corp.
FGE
Sep 22, 1987K872509LINDEN STONE EXTRACTION BALLOON
Hobbs Medical, Inc.
FGE
Sep 21, 1987K872458AN3200 DOUBILET DRAIN
H.W. Andersen Products, Inc.
FGE
May 15, 1987K861291GASTROTOPO
Houston Biomedical, Inc.
FGE

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