Cook, Inc.
Cook, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2015, with 264 FDA device recalls on record.
Top product codes for Cook, Inc.
FDA recalls by Cook, Inc.
10 most recent of 264- Z-0388-2022 — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Z-0387-2022 — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Z-0414-2022 — Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
- Z-0222-2022 — Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
- Z-0223-2022 — Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
- Z-0185-2022 — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
- Z-0186-2022 — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
- Z-0960-2021 — Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
- Z-0598-2021 — Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Z-0594-2021 — Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cook, Inc.
1–100 of 190- K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
- K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
- K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
- K131772 — CANTATA(R) 2.9 MICROCATHETER
- K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER
- K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
- K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
- K131206 — COOK CERVICAL RIPENING BALLOON
- K132334 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
- K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
- K130766 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
- K122917 — CODA BALLOON CATHETER
- K130293 — ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K130444 — H-30 HOLMIUM LASER SYSTEM
- K122940 — ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
- K123707 — ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
- K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
- K122796 — CXI SUPPORT CATHETER
- K113300 — ATB ADVANCE PTA DILATATION CATHETER
- K112185 — FOURSNARE VASCULAR RETRIEVAL SNARE
- K111244 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
- K110009 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
- K101450 — CANTATA MICROCATHETER
- K101728 — FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
- K101877 — OCCLUSION BALLOON CATHETER MODEL OBC
- K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
- K093209 — FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
- K093469 — CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
- K093052 — CROSSCATH SUPPORT CATHTER
- K091385 — APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
- K091527 — ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K090822 — ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
- K090624 — COOK MREYE EMBOLIZATION COILS
- K090133 — CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
- K080737 — MIRAFLEX HIGH FLOW MICROCATHETER
- K080037 — MODIFICATION TO ZILVER 635 BILIARY STENT
- K081113 — COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
- K081690 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
- K073627 — FLEXOR EVAC ASPIRATION CATHETER
- K073378 — ADVANCE 18LP PTA DILATATION CATHETER
- K072625 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
- K072724 — CXI SUPPORT CATHETER
- K072240 — GUNTHER TULIP VENA CAVA FILTER
- K072148 — CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
- K071640 — VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
- K070410 — COOK MICROWIRE WIRE GUIDE
- K063619 — FLIPPER DETACHABLE EMBOLIZATION COILS
- K063252 — ATB ADVANCED PTA DILATATION CATHETER
- K060174 — SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
- K052539 — COOK FORMULA 418 BILIARY STENT SYSTEM
- K052841 — MIRA-FLEX 18 MICROCATHETER
- K052834 — MREYE EMBOLIZATION COIL
- K042691 — VERTEFIX VERTEBROPLASTY PROCEDURE SET
- K052036 — ATB ADVANCE PTA DILATATION CATHETER
- K051785 — FORMULA 418 BILIARY STENT
- K041849 — TURBO-FLO PICC
- K051124 — ZILVER 635 BILIARY STENT
- K043509 — GUNTHER TULIP VENA CAVA FILTER SET
- K050698 — MODIFICATION TO:ZILVER 518 BILIARY STENT
- K043481 — MODIFICATION TO: ZILVER 635 BILIARY STENT
- K042611 — LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
- K042518 — ZILVER 518 BILIARY STENT
- K033843 — SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
- K041044 — CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
- K033875 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K040505 — ZILVER 635 BILIARY STENT
- K032274 — COOK FIVE LUMEN CENTRAL VENOUS CATHETER
- K033348 — ZILVER 518 BILIARY STENT
- K032869 — COOK CODA BALLOON CATHETER
- K032426 — GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
- K032931 — PTA BALLOON CATHETER
- K031966 — ENK FIBEROPTIC ATOMIZER SET
- K031821 — MODIFICATION TO COOK ZILVER BILIARY STENT
- K030841 — COOK GASTRIC SIZING BALLOON CATHETER
- K031766 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K021557 — SPECTRUM SILICONE CATHETER
- K023504 — MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K022552 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K021920 — 7.0 FR. ENDOBRONCHIAL BLOCKER
- K013182 — TRIPLE LUMEN CENTRAL VENOUS CATHETER
- K013865 — TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
- K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
- K010601 — FANELLI BILIARY STENT
- K011812 — SPECTRUM VENTRICULAR CATHETER
- K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
- K010450 — LIVER TAMPONADE BALLOON
- K010242 — COOK ZILVER BILIARY STENT
- K002286 — LDOB OCCLUSION BALLOON CATHETER
- K002254 — COOK PRESSURE MONITORING CATHETER
- K001985 — INTRODEUCE DOUBLE LUMEN INTRODUCER
- K010034 — DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
- K002288 — ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
- K000651 — DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
- K000855 — GUNTHER TULIP VENA CAVA MREYE FILTER SET
- K001087 — PTA BALLOON CATHETER
- K993455 — FLIPPER DETACHABLE EMBOLIZATION COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.