Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

175 results for "Cook Incorporated"
1–24 of 175
Search insights Median review: 225d Cleared: 99% Top manufacturer: Cook Incorporated Lead specialty: Cardiovascular
Cleared Mar 08, 2024
Nest VT Vitrification Device
K233177 · MQK
Cook Incorporated
Obstetrics & Gynecology · 162d
Cleared May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · MMX
Cook Incorporated
Cardiovascular · 293d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098 · OQY
Cook Incorporated
Obstetrics & Gynecology · 28d
Cleared Apr 06, 2021
Endovascular Dilator and Sets
K210734 · DRE
Cook Incorporated
Cardiovascular · 26d
Cleared Feb 16, 2021
Extra Large Check-Flo Introducer
K203670 · DYB
Cook Incorporated
Cardiovascular · 62d
Cleared Jan 29, 2020
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc,...
K191498 · LJE
Cook Incorporated
Gastroenterology & Urology · 238d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Dec 12, 2019
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino...
K193133 · JOH
Cook Incorporated
Anesthesiology · 30d
Cleared Dec 12, 2019
Lumax Guiding Catheter
K191163 · DQY
Cook Incorporated
Cardiovascular · 225d
Cleared Oct 11, 2019
McLean-Ring Enteral Feeding Tube Set
K190084 · KNT
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Aug 05, 2019
UPJ Occlusion Balloon Catheter
K183323 · EYB
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Jul 22, 2019
Roadrunner PC Wire Guide, Olcott Torque Device
K182985 · DQX
Cook Incorporated
Cardiovascular · 266d
Cleared Jul 16, 2019
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
K183051 · LJE
Cook Incorporated
Gastroenterology & Urology · 256d
Cleared Jun 26, 2019
Deflectable Brush Biopsy Set
K191485 · FDX
Cook Incorporated
Gastroenterology & Urology · 22d
Cleared Jun 26, 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · KGC
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Jun 17, 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · EYB
Cook Incorporated
Gastroenterology & Urology · 263d
Cleared May 29, 2019
Peel-Away Introducer
K182403 · FED
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared May 17, 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer...
K191015 · MQF
Cook Incorporated
Obstetrics & Gynecology · 30d
Cleared May 17, 2019
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part...
K183035 · LJE
Cook Incorporated
Gastroenterology & Urology · 197d
Cleared May 17, 2019
Cook Unimpregnated Central Venous Catheter
K182252 · FOZ
Cook Incorporated
General Hospital · 270d
Cleared May 01, 2019
Brush Biopsy Set
K182231 · FDX
Cook Incorporated
Gastroenterology & Urology · 257d
Cleared Apr 25, 2019
Multi-Sideport Catheter Infusion Set
K182071 · KRA
Cook Incorporated
Cardiovascular · 267d
Cleared Apr 23, 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971 · FAD
Cook Incorporated
Gastroenterology & Urology · 273d
Cleared Apr 04, 2019
Park Blade Septostomy Catheter
K182399 · DXF
Cook Incorporated
Cardiovascular · 212d