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
39337–39360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2013
MAK OSS FEMORAL KNEE COMPONENTS
K131393 · KRO
Biomet Orthopedics Corp.
Orthopedic · 162d
Cleared Oct 24, 2013
LOTUS
K131427 · KWP
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Oct 24, 2013
(QUANTA SYSTEM) SURGICAL LASER FIBERS
K131473 · GEX
Quanta System Spa
General & Plastic Surgery · 155d
Cleared Oct 24, 2013
OMBRA TABLE TOP COMPRESSOR
K131881 · BTI
Trudell Medical Intl.
Anesthesiology · 121d
Cleared Oct 24, 2013
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING...
K131887 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 121d
Cleared Oct 24, 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 121d
Cleared Oct 24, 2013
ULTRACEM
K132255 · EMA
Ultradent Products Inc. / Oratech, LLC
Dental · 97d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · NBW
Delbio Incorporation
Chemistry · 90d
Cleared Oct 24, 2013
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
K132510 · HTN
Biopro, Inc.
Orthopedic · 73d
Cleared Oct 24, 2013
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS...
K132512 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 73d
Cleared Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 71d
Cleared Oct 24, 2013
ACUSON S1000 / S2000 / S3000
K132804 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 48d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · JJX
Bionime Corporation
Chemistry · 29d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971 · DRG
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Oct 23, 2013
CALIX LUMBAR SPINAL IMPLANT SYSTEM
K131350 · MAX
X-Spine Systems, Inc.
Orthopedic · 166d
Cleared Oct 23, 2013
DYNAMESH -CICAT
K131530 · FTL
Feg Textiltechnik Forschungs-Und...
General & Plastic Surgery · 148d
Cleared Oct 23, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590 · FPD
Philips Medical Systems
Gastroenterology & Urology · 145d
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · JJY
Randox Laboratories, Ltd.
Chemistry · 104d
Cleared Oct 23, 2013
MARIGEN WOUND DRESSING
K132343 · KGN
Kerecis Limited
General & Plastic Surgery · 85d
Cleared Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 78d
Cleared Oct 23, 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · GDW
Covidien, LLC
General & Plastic Surgery · 75d
Cleared Oct 23, 2013
VARIAX 2 SYSTEM
K132502 · HRS
Stryker Trauma AG
Orthopedic · 75d
Cleared Oct 23, 2013
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K132627 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 62d