Cook, Inc.
Cook, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2015, with 264 FDA device recalls on record.
Clearances by Cook, Inc. — page 2
101–190 of 190- K992121 — EMBOLIZATION COIL SYSTEM
- K992198 — URETHANE PICC LINE MODEL UPICS-
- K991985 — COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
- K990753 — GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K990726 — ENVY GUIDING CATHETER
- K982333 — MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
- K982500 — CHAIT CECOSTOMY CATHETER
- K983217 — ROWE DUAL-CHECK VALVE
- K983771 — STRATEGY CORONARY WIRE GUIDE
- K981886 — VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K974774 — ENVY GUIDING CATHETER
- K980390 — PTA BALLOON CATHETER
- K981906 — MODIFICATION FOR PTA BALLOON CATHETER
- K972800 — PTA BALLOON CATHETER
- K973565 — QUICK-CARE BIOPSY NEEDLE
- K962167 — BRONCHIAL BLOCKER
- K963565 — MRI NEEDLES
- K961668 — MICROFERRET CATHETER
- K962761 — REIGEL TUNNELING DEVICE
- K962097 — VENTRICULAR CATHETER SET
- K950118 — ABRM CATHETER
- K940973 — MULLAN GANGLION MICROCOMPRESSION SET
- K945201 — COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
- K940189 — COIL POSITIONER SET
- K940982 — ARTERIAL EMBOLIZATION DEVICE (KRD)
- K940550 — COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
- K941092 — MURDOCH LAPAROSCOPE LENS CLEANER
- K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
- K931936 — GIANTURCO-HELFRICH HERNIS MESH
- K933754 — CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
- K924358 — ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
- K923738 — HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
- K920823 — WELTER SNARE RETRIEVER
- K923334 — MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
- K920891 — ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
- K923107 — BODY BAND RESTRAINT STRAP SET
- K920824 — ROADRUNNER RLTF GUIDE WIRE
- K923108 — WRIST RESTRAINT FOR GE9800 C.T. TABLES
- K923109 — ADULT CHIN STRAP FOR CT TABLES
- K923110 — SCAN BAND
- K923111 — ARM EXTENDER FOR CT TABLES
- K923112 — ANGIO-BAND
- K923114 — HEAD RESTRAINT FOR CT TABLES
- K923106 — SCAN BAND
- K921654 — MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
- K921191 — GIANTURCO-ROSCH BILIARY Z STENT
- K914856 — VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
- K913258 — DISPOSABLE INTROSSEOUS INFUSION NEEDLES
- K915409 — INTRAOSSEOUS ACCESS NEEDLE
- K891411 — GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
- K914029 — ESOPHAGEAL Z-STENT
- K900677 — ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
- K902999 — VASCULAR RETRIEVAL FORCEPS
- K901337 — HILAL EMBOLIZATION MICROCOIL(TM)
- K903124 — LAPAROSCOPIC ACCESS SHEATH SET
- K903146 — HYSTEROSCOPY SHEATH SET
- K903858 — COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
- K901899 — ROADRUNNER WIRE GUIDE
- K903707 — DEFLECTING WIRE GRASPER
- K902944 — WITTICH NITINOL STONE BASKET
- K902945 — COPE NITINOL STONE BASKET
- K902905 — COOK CORONARY GUIDING CATHETER
- K900200 — COOK STEREOTAXIC GUIDE
- K900852 — MAGNET RETRIEVAL CATHETER
- K895044 — DUAL GUIDE INTRODUCER CATHETER
- K882610 — COOK-GIANTURCO BILIARY Z STENT
- K884291 — COOK HYSTEROCATH(TM)
- K883723 — FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
- K882771 — EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
- K882052 — OMEGA NV(TM) BALLOON DILATATION CATHETER
- K880722 — COATING FOR WIRE GUIDE
- K882796 — SLIP-COAT(TM) CATHETERS
- K873606 — MODIFIED COPE SUTURE ANCHOR
- K870215 — DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
- K870181 — JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
- K864101 — COOK (R) VEIN GRAFT RING MARKERS
- K851243 — GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
- K851241 — GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
- K851244 — GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
- K851242 — GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
- K832178 — AMPLATZ HEPARIN COATED CATHETER
- K831185 — CARDIAC OUTPUT MEASURE SYSTEM
- K801031 — BLADE SEPTOSTOMY CATHETER
- K772011 — WHOLEY OCCLUSION BALLOON CATHETER
- K781393 — VARIABLE STIFFNESS WIRE GUIDE
- K770523 — NEEDLE, BIOPSY, BOYD, LUNG
- K770913 — UROLOGICAL BIOPSY BRUSH SET
- K770522 — CATHETER, GRUNTZIG, BALLON
- K770122 — PROSTATE BIOPSY NEEDLE
- K760858 — RUTNER UNIVERSAL WEDGE CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.