FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29209–29232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2017
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -...
K163468 · MUM
Cook Ireland, Ltd.
Gastroenterology & Urology · 143d
Cleared May 04, 2017
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
K163615 · GEI
Carefusion 2200, Inc.
General & Plastic Surgery · 133d
Cleared May 04, 2017
VIPER PRIME™ Screws with Fenestrations
K170543 · NKB
Medos International SARL
Orthopedic · 69d
Cleared May 04, 2017
Nucleus Image Management System
K171130 · LLZ
Nucleushealth, LLC
Radiology · 17d
Cleared May 04, 2017
Arthrex SwiveLock Anchors
K171141 · MAI
Arthrex, Inc.
Orthopedic · 16d
Cleared CT May 03, 2017
Asahi ViE-U Series Dialyzer
K162248 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 266d
Cleared May 03, 2017
Optilite Rheumatoid Factor Kit
K162263 · DHR
The Binding Site Group , Ltd.
Immunology · 265d
Cleared May 03, 2017
The IQool System
K162523 · NZE
Braincool AB
Cardiovascular · 236d
Cleared May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
K162756 · HRN
Phakos
Ophthalmic · 215d
Cleared May 03, 2017
C.T.M. Mobility Scooter
K162952 · INI
Chien TI Enterprise Co., Ltd.
Physical Medicine · 191d
Cleared May 03, 2017
HALF DOME Posterior Lumbar Interbody System
K163481 · MAX
Astura Medical
Orthopedic · 142d
Cleared May 03, 2017
PrisMax Control Unit
K163530 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 138d
Cleared May 03, 2017
QZA and RS Dental Implant Systems
K163640 · DZE
Trinon Titanium GmbH
Dental · 131d
Cleared May 03, 2017
A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
K163683 · DXN
A&D Company, Ltd.
Cardiovascular · 126d
Cleared May 03, 2017
Surgi Max Ultra
K170107 · GEI
Elliquence, LLC
General & Plastic Surgery · 111d
Cleared May 03, 2017
Hee HR Mini
K170269 · OHT
Oriental Inspiration Limited
General & Plastic Surgery · 96d
Cleared May 03, 2017
KISSloc Suture System
K170440 · HTN
Arthrosurface, Inc.
Orthopedic · 78d
Cleared May 03, 2017
Iridex TruFocus LIO Premiere
K170718 · GEX
Iridex Corporation
General & Plastic Surgery · 55d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 03, 2017
Silhouette Featherlift
K171005 · GAW
Silhouette Lift, Inc.
General & Plastic Surgery · 29d
Cleared May 02, 2017
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
K160781 · KGO
Semperit Investments Asia Pte , Ltd.
General Hospital · 406d
Cleared May 02, 2017
iGlucose Blood Glucose Monitoring System
K161790 · NBW
Bionime Corporation
Chemistry · 307d
Cleared May 02, 2017
Airworks Nebulizer pe1200m
K162041 · CAF
Convexity Scientific, LLC
Anesthesiology · 281d
Cleared May 02, 2017
Locking Plate System
K162380 · HRS
Beijing Keyi Medical Device...
Orthopedic · 251d