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.

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

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175,820 results
35137–35160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2015
Acclarix Diagnostic Ultrasound System
K150999 · IYO
Edan Instruments, Inc.
Radiology · 21d
Cleared May 05, 2015
Pasture 60S Surgical Mask
K141875 · FXX
Pasture Pharma Pte, Ltd.
General Hospital · 298d
Cleared May 05, 2015
Stryker MEDPOR TITAN 3D Orbital Floor Implant
K142568 · JEY
Stryker
Dental · 235d
Cleared May 05, 2015
ILUMIEN, Drageonfly OPTIS Imaging Catheter
K150237 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 92d
Cleared May 05, 2015
Terumo Circuit Tubing
K150536 · DWF
Terumo Cardiovascular Systems...
Cardiovascular · 63d
Cleared May 04, 2015
Maxima PRO 45L
K141576 · EFB
Kavo DO Brasil Industria E Comercio Ltda
Dental · 326d
Cleared May 04, 2015
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
K141910 · KNW
Biologic Therapies, Inc.
Gastroenterology & Urology · 293d
Cleared May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
K142038 · LSR
Euroimmun US
Microbiology · 280d
Cleared May 04, 2015
NovaCross Microcatheter
K143608 · DQY
Nitiloop , Ltd.
Cardiovascular · 136d
Cleared May 04, 2015
Powerheart G5 AED
K143714 · MKJ
Cardiac Science Corporation
Cardiovascular · 126d
Cleared May 04, 2015
Modified Bencox Hip System
K150007 · LPH
Corentec Co., Ltd.
Orthopedic · 122d
Cleared May 04, 2015
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · GEH
Erbe USA, Inc.
General & Plastic Surgery · 14d
Cleared May 02, 2015
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
K143734 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 123d
Cleared May 02, 2015
OneStep Pediatric CPR Multi-Function Electrode
K150055 · MKJ
Bio-Detek, Inc.
Cardiovascular · 110d
Cleared May 02, 2015
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
K150198 · MKJ
Bio-Detek, Inc.
Cardiovascular · 93d
Cleared May 01, 2015
BGM009 BLOOD GLUCOSE MONITORING SYSTEM
K141036 · NBW
Apex BioTechnology Corp.
Chemistry · 374d
Cleared May 01, 2015
INVISIPORT
K141146 · LJT
Stealth Therapeutics, Incorporated
General Hospital · 361d
Cleared CT May 01, 2015
COVA MONITORING SYSTEM
K142087 · MWI
Tosense, Inc.
Cardiovascular · 275d
Cleared May 01, 2015
MERITS TRANSFORMER POWER SCOOTER, S941
K142162 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 268d
Cleared May 01, 2015
Pyrenees Cervical Plate System
K142212 · KWQ
K2m, Inc.
Orthopedic · 262d
Cleared May 01, 2015
2D Mercy TAPE & 3D Mercy TAPE
K142469 · PIR
Children'S Mercy Hospital
General Hospital · 240d
Cleared May 01, 2015
Helio A7 Manual Wheelchair, Move Manual Wheelchair
K143101 · IOR
Motion Composites
Physical Medicine · 184d
Cleared May 01, 2015
Bifix Temp
K143212 · EMA
Voco GmbH
Dental · 172d
Cleared May 01, 2015
Sonendo GentleWave System
K143448 · ELC
Sonendo, Inc.
Dental · 150d