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
24145–24168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2018
AURORA™ Screw System
K182989 · HWC
MiRus, LLC
Orthopedic · 50d
Cleared Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Dec 18, 2018
ValPro 2 Plus, VaPro 2 Plus Pocket
K183253 · GBM
Hollister Incorporated
Gastroenterology & Urology · 27d
Cleared Dec 17, 2018
Handheld VitalSigns Monitoring System
K172965 · MWI
Visiomed Technology Co.,Ltd
Cardiovascular · 447d
Cleared Dec 17, 2018
Met One Czar Anterior Cervical Plate System
K180772 · KWQ
Met One Technologies
Orthopedic · 269d
Cleared Dec 17, 2018
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid...
K180878 · DJC
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 258d
Cleared Dec 17, 2018
Tyto Stethoscope (OTC)
K181612 · DQD
Tyto Care , Ltd.
Cardiovascular · 181d
Cleared Dec 17, 2018
Phoenix 2.4mm Atherectomy Plus System
K181877 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 157d
Cleared Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
K182001 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 144d
Cleared Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387 · FMF
Novo Nordisk, Inc.
General Hospital · 104d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 17, 2018
FlowTriever Retrieval/Aspiration System
K183198 · QEW
Inari Medical
Cardiovascular · 28d
Cleared Dec 17, 2018
Reusable Silicone Cover CPRmeter 2
K183348 · LIX
Laerdal Medical AS
Cardiovascular · 14d
Cleared Dec 14, 2018
SCIg60 Infusion System
K173783 · PKP
Emed Technologies Corporation
General Hospital · 366d
Cleared Dec 14, 2018
CAPI 3 HEMOGLOBIN(E)
K180762 · GKA
Sebia
Hematology · 266d
Cleared Dec 14, 2018
Arthrex SwiveLock Anchors
K180768 · MAI
Arthrex, Inc.
Orthopedic · 266d
Cleared Dec 14, 2018
Xcess Guiding Catheter
K180797 · DQY
Curatia Medical Co.
Cardiovascular · 262d
Cleared Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820 · HKX
Crystalvue Medical Corporation
Ophthalmic · 260d
Cleared Dec 14, 2018
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid...
K180879 · DKZ
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 255d
Cleared Dec 14, 2018
iCertainty
K181269 · DPW
Rfpi
General & Plastic Surgery · 214d
Cleared CT Dec 14, 2018
Honda Walking Assist Device
K181294 · PHL
Honda Motor Company, Ltd.
Neurology · 212d
Cleared Dec 14, 2018
C.T.M Mobility Scooter
K181344 · INI
Chien TI Enterprise Co., Ltd.
Physical Medicine · 207d
Cleared Dec 14, 2018
NRFit Syringe
K181374 · QEH
Jiangsu Caina Medical Co.,Ltd
General Hospital · 204d
Cleared Dec 14, 2018
Affixus Natural Nail System Humeral Nail
K181827 · HSB
Zimmer GmbH
Orthopedic · 158d