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Cook Incorporated

175 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
NCompass Nitinol Stone Extractors (K173009)Cook Incorporated2017-11-07
Rhapsody H-30 Holmium Laser System (K172325)Cook Incorporated2017-10-26
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 (K172527)Cook Incorporated2017-10-19
Liberator Beacon Tip Locking Stylet (K170298)Cook Incorporated2017-10-18
Peel-Away Introducer Set (K170020)Cook Incorporated2017-09-28
Entuit Start Initial Placement Gastrostomy Set (K170323)Cook Incorporated2017-09-14
Salle Intraoperative Pyeloplasty Stent Set (K170010)Cook Incorporated2017-08-28
Liver Access and Biopsy Sets (K171853)Cook Incorporated2017-08-24
Approach CTO Microwire Guide (K171897)Cook Incorporated2017-08-21
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729)Cook Incorporated2017-08-11
Performer Introducer (K171999)Cook Incorporated2017-07-31
Williams Cystoscopic Injection Needle (K171602)Cook Incorporated2017-07-28
Bunegin-Albin Air Aspiration Set (K163031)Cook Incorporated2017-07-27
Soules Intrauterine Insemination Catheter (K163318)Cook Incorporated2017-07-14
Needle's Eye Snare Retrieval Set - 54cm (K163353)Cook Incorporated2017-07-11
Kwart Retro-Inject Ureteral Stent (K162109)Cook Incorporated2017-06-07
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448)Cook Incorporated2017-05-26
Tao Brush I.U.M.C. Endometrial Sampler (K170603)Cook Incorporated2017-05-24
Cook Holmium Laser Fiber (K163197)Cook Incorporated2017-05-24
Barone Jejunostomy Catheter Set (K160567)Cook Incorporated2017-05-18
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509)Cook Incorporated2017-05-18
van Andel Dilatation Catheter (K170616)Cook Incorporated2017-04-28
C-Flex Ureteral Stent Set (K162104)Cook Incorporated2017-04-24
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622)Cook Incorporated2017-03-31
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set (K170008)Cook Incorporated2017-02-28
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200)Cook Incorporated2017-02-17
Advance 14LP Low Profile PTA Balloon Dilatation Catheter (K170193)Cook Incorporated2017-02-13
Universa Firm Ureteral Stents and Stent Sets (K161236)Cook Incorporated2017-01-27
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K161504)Cook Incorporated2017-01-06
CXI Support Catheter (K160884)Cook Incorporated2016-11-22
Torcon NB Advantage Catheters (K161822)Cook Incorporated2016-10-27
Turbo-Flo PICC Sets (K161496)Cook Incorporated2016-10-07
uVue HSG/SHG Catheter (K160217)Cook Incorporated2016-10-06
Aprima Smartesis Centesis Pump (K161002)Cook Incorporated2016-09-28
Emergency Transtracheal Airway Catheter (K153761)Cook Incorporated2016-09-22
Indy OTW Vascular Retriever (K160593)Cook Incorporated2016-09-02
Hilal Embolization MicroCoils (K160219)Cook Incorporated2016-08-03
5.0 Fr Arndt Endobronchial Blocker Set (K160542)Cook Incorporated2016-08-02
CrossCath Support Catheter (K161801)Cook Incorporated2016-07-29
Cook Intraosseous Infusion Needles (K160887)Cook Incorporated2016-07-26
Gianturco-Roehm Bird’s Nest Vena Cava Filter (K161218)Cook Incorporated2016-07-22
Ultrathane Endoureterotomy Stent Set (K160891)Cook Incorporated2016-06-24
Nester Embolization Coils, Tornado Embolization Coils (K153778)Cook Incorporated2016-05-19
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (K160223)Cook Incorporated2016-04-08
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select (K153430)Cook Incorporated2016-03-07
Universa Soft Ureteral Stents and Stent Sets (K151051)Cook Incorporated2016-01-11
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (K151018)Cook Incorporated2016-01-08
Flexipet Denuding Pipette, Flexipet Manipulation Pipette (K150748)Cook Incorporated2015-12-18
MReye Embolization Coils (K150931)Cook Incorporated2015-12-18
MReye Flipper Detachable Embolization Coil and Delivery System (K150964)Cook Incorporated2015-12-18
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (K152524)Cook Incorporated2015-09-30
Flexor Radial Hydrophilic Introducer Access Set (K152044)Cook Incorporated2015-08-14
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (K142829)Cook Incorporated2015-07-28
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set (K142819)Cook Incorporated2015-07-24
Retracta Detachable Embolization Coil (K151676)Cook Incorporated2015-07-22
Heavy Double Flexible Tipped Wire Guide (K150802)Cook Incorporated2015-05-28
Vital-Port Vascular Access System Power Injectable Port (K150733)Cook Incorporated2015-05-21
Coda LP Balloon Catheter (K150970)Cook Incorporated2015-05-12
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER (K141322)Cook Incorporated2015-03-27
COOK HOLMIUM LASER FIBER (K133788)Cook Incorporated2015-03-18
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085)Cook Incorporated2014-11-18
MICROPUNCTURE INTRODUCER SET (K133114)Cook Incorporated2014-07-03
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM (K140169)Cook Incorporated2014-05-21
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (K132885)Cook Incorporated2013-10-11
COOK HOLMIUM LASER FIBER (K124030)Cook Incorporated2013-07-01
EQUAFLOW MULTIVALVE INFUSION CATHETER (K123235)Cook Incorporated2013-02-14
RETRACTA DETACHABLE EMBOLIZATION COIL (K123712)Cook Incorporated2013-01-03
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR (K120468)Cook Incorporated2012-07-06
CXI TRIFORCE (K111263)Cook Incorporated2011-07-25
APPROACH PRO ST WIRE GUIDE (K110163)Cook Incorporated2011-02-25
SPECTRUM TURBO-JECT PICC SET (K100974)Cook Incorporated2010-05-06
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (K081768)Cook Incorporated2008-12-23
APPROACH CTO WIRE GUIDE (K081337)Cook Incorporated2008-08-08
VENA CAVA FILTER (K073528)Cook Incorporated2008-02-27
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER (K060224)Cook Incorporated2006-03-06
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Every clearance here is in the API, with alerts when new ones post.