FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
34561–34584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 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
Cleared May 01, 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · NHA
Zimmer Dental, Inc.
Dental · 140d
Cleared May 01, 2015
Stryker MIS Attachments and Cutting Accessories
K143540 · HBE
Stryker Corporation
Neurology · 137d
Cleared May 01, 2015
Nuance FLOW
K143679 · EBF
Den-Mat Holdings, LLC
Dental · 128d
Cleared May 01, 2015
V10 system
K150035 · PBX
Viora , Ltd.
General & Plastic Surgery · 112d
Cleared May 01, 2015
Invictus Medical GelShield
K150243 · FMP
Invictus Medical, Inc.
General Hospital · 88d
Cleared May 01, 2015
ADVIA Centaur TSH3-Ultra
K150403 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared May 01, 2015
G7 Dual Mobility System
K150522 · LPH
Biomet, Inc.
Orthopedic · 60d
Cleared May 01, 2015
Terumo Pump Tubing
K150542 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 59d
Cleared May 01, 2015
Vaginal Moisturizing Gel
K150615 · NUC
Combe Incorporated
Obstetrics & Gynecology · 52d
Cleared May 01, 2015
Rush Medullary Pins
K150626 · HTY
Zimmer, Inc.
Orthopedic · 51d
Cleared May 01, 2015
Digital Dental Intra Oral Sensor, EzSensor Smart
K150797 · MUH
Rayence Co., Ltd.
Radiology · 36d
Cleared May 01, 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System,...
K150818 · KTT
Zimmer, Inc.
Orthopedic · 35d
Cleared May 01, 2015
Tablo Console with Wireless Capability
K150880 · KDI
Outset Medical
Gastroenterology & Urology · 30d
Cleared May 01, 2015
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
K150891 · FCG
Covidien, LLC( Formerly Beacon...
General & Plastic Surgery · 29d