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Cook Incorporated

FDA 510(k) & PMA Approved Devices — 146 products

Total Devices146
Categories52
Latest FDA decision2024-03-08
TypeNumberDevice NameCodeDateActions
510(k) K233177 Nest VT Vitrification DeviceMQK2024-03-08 View
510(k) K222254 Gunther Tulip Vena Cava Filter Retrieval SetMMX2023-05-16 View
510(k) K223098 Bakri Essential Postpartum BalloonOQY2022-10-28 View
510(k) K210734 Endovascular Dilator and SetsDRE2021-04-06 View
510(k) K203670 Extra Large Check-Flo IntroducerDYB2021-02-16 View
510(k) K191498 Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocLJE2020-01-29 View
510(k) K190903 Lawson Retrograde Nephrostomy Wire Puncture SetLJE2019-12-16 View
510(k) K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetJOH2019-12-12 View
510(k) K191163 Lumax Guiding CatheterDQY2019-12-12 View
510(k) K190084 McLean-Ring Enteral Feeding Tube SetKNT2019-10-11 View
510(k) K183323 UPJ Occlusion Balloon CatheterEYB2019-08-05 View
510(k) K182985 Roadrunner PC Wire Guide, Olcott Torque DeviceDQX2019-07-22 View
510(k) K183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE2019-07-16 View
510(k) K182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetKGC2019-06-26 View
510(k) K191485 Deflectable Brush Biopsy SetFDX2019-06-26 View
510(k) K182695 Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB2019-06-17 View
510(k) K182403 Peel-Away IntroducerFED2019-05-29 View
510(k) K183035 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE2019-05-17 View
510(k) K191015 Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)MQF2019-05-17 View
510(k) K182252 Cook Unimpregnated Central Venous CatheterFOZ2019-05-17 View

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