Cook Incorporated
Cook Incorporated holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2024, with 85 FDA device recalls on record.
Clearances by Cook Incorporated — page 2
101–175 of 175- K173009 — NCompass Nitinol Stone Extractors
- K172325 — Rhapsody H-30 Holmium Laser System
- K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
- K170298 — Liberator Beacon Tip Locking Stylet
- K170020 — Peel-Away Introducer Set
- K170323 — Entuit Start Initial Placement Gastrostomy Set
- K170010 — Salle Intraoperative Pyeloplasty Stent Set
- K171853 — Liver Access and Biopsy Sets
- K171897 — Approach CTO Microwire Guide
- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K171999 — Performer Introducer
- K171602 — Williams Cystoscopic Injection Needle
- K163031 — Bunegin-Albin Air Aspiration Set
- K163318 — Soules Intrauterine Insemination Catheter
- K163353 — Needle's Eye Snare Retrieval Set - 54cm
- K162109 — Kwart Retro-Inject Ureteral Stent
- K162448 — White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
- K163197 — Cook Holmium Laser Fiber
- K170603 — Tao Brush I.U.M.C. Endometrial Sampler
- K160509 — Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
- K160567 — Barone Jejunostomy Catheter Set
- K170616 — van Andel Dilatation Catheter
- K162104 — C-Flex Ureteral Stent Set
- K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
- K170008 — Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
- K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- K170193 — Advance 14LP Low Profile PTA Balloon Dilatation Catheter
- K161236 — Universa Firm Ureteral Stents and Stent Sets
- K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
- K160884 — CXI Support Catheter
- K161822 — Torcon NB Advantage Catheters
- K161496 — Turbo-Flo PICC Sets
- K160217 — uVue HSG/SHG Catheter
- K161002 — Aprima Smartesis Centesis Pump
- K153761 — Emergency Transtracheal Airway Catheter
- K160593 — Indy OTW Vascular Retriever
- K160219 — Hilal Embolization MicroCoils
- K160542 — 5.0 Fr Arndt Endobronchial Blocker Set
- K161801 — CrossCath Support Catheter
- K160887 — Cook Intraosseous Infusion Needles
- K161218 — Gianturco-Roehm Birds Nest Vena Cava Filter
- K160891 — Ultrathane Endoureterotomy Stent Set
- K153778 — Nester Embolization Coils, Tornado Embolization Coils
- K160223 — VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
- K153430 — Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
- K151051 — Universa Soft Ureteral Stents and Stent Sets
- K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
- K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette
- K150931 — MReye Embolization Coils
- K150964 — MReye Flipper Detachable Embolization Coil and Delivery System
- K152524 — Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
- K152044 — Flexor Radial Hydrophilic Introducer Access Set
- K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification +6 more
- K142819 — Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
- K151676 — Retracta Detachable Embolization Coil
- K150802 — Heavy Double Flexible Tipped Wire Guide
- K150733 — Vital-Port Vascular Access System Power Injectable Port
- K150970 — Coda LP Balloon Catheter
- K141322 — ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
- K133788 — COOK HOLMIUM LASER FIBER
- K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
- K133114 — MICROPUNCTURE INTRODUCER SET
- K140169 — VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
- K132885 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
- K124030 — COOK HOLMIUM LASER FIBER
- K123235 — EQUAFLOW MULTIVALVE INFUSION CATHETER
- K123712 — RETRACTA DETACHABLE EMBOLIZATION COIL
- K120468 — NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
- K111263 — CXI TRIFORCE
- K110163 — APPROACH PRO ST WIRE GUIDE
- K100974 — SPECTRUM TURBO-JECT PICC SET
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
- K081337 — APPROACH CTO WIRE GUIDE
- K073528 — VENA CAVA FILTER
- K060224 — MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.