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
33289–33312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2015
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay...
K151906 · PGI
Luminex Corporation
Microbiology · 85d
Cleared Oct 06, 2015
ARIES System
K151917 · OOI
Luminex Corporation
Chemistry · 85d
Cleared Oct 06, 2015
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
K152369 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 46d
Cleared Oct 06, 2015
AXIOS Stent and Delivery System
K152572 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Oct 05, 2015
ADX6000 Portable X-Ray System
K143494 · IZL
Dexcowin Co., Ltd.
Radiology · 300d
Cleared Oct 05, 2015
CygneX I System
K143560 · IYE
Accuthera, Inc.
Radiology · 293d
Cleared Oct 05, 2015
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
K151500 · KWS
Custom Orthopaedic Solutions
Orthopedic · 123d
Cleared Oct 05, 2015
STERISPINE PS
K151747 · NKB
Safe Orthopaedics
Orthopedic · 98d
Cleared Oct 05, 2015
Ultraviolet Sunlamps
K151841 · LEJ
Wolff System Technology Corp.
General & Plastic Surgery · 91d
Cleared Oct 05, 2015
Ultrasound Scanner System BK2300
K151910 · IYN
Bk Medical Aps
Radiology · 84d
Cleared Oct 05, 2015
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split...
K152025 · DJR
Assure Tech. Co., Ltd.
Chemistry · 75d
Cleared Oct 02, 2015
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE...
K141656 · NBW
Philosys, Inc.
Chemistry · 469d
Cleared Oct 02, 2015
Valeo Spacer System and Valeo II Interbody Fusion Device System
K143518 · MAX
Amedica Corp.
Orthopedic · 294d
Cleared Oct 02, 2015
SICAT OPTIMOTION
K143655 · MQC
Sicat GmbH & Co. KG
Dental · 283d
Cleared Oct 02, 2015
One Step hCG Pregnancy Test
K150063 · LCX
Coretests, Inc.
Chemistry · 262d
Cleared Oct 02, 2015
ARGOS
K150754 · MXK
Santec Corporation
Ophthalmic · 193d
Cleared Oct 02, 2015
CorPath 200 System
K150892 · DXX
Corindus, Inc.
Cardiovascular · 183d
Cleared Oct 02, 2015
zensor system
K151027 · MHX
Intelesens Limited
Cardiovascular · 168d
Cleared Oct 02, 2015
LOSPA IS Spinal System
K151408 · MAX
Corentec Co., Ltd.
Orthopedic · 129d
Cleared Oct 02, 2015
OrthoVis Web Portal
K151501 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 120d
Cleared Oct 02, 2015
iSy Implant System
K151599 · DZE
Altatec GmbH
Dental · 112d
Cleared Oct 02, 2015
TiTHON Staple with OsseoTi Technology
K151615 · JDR
Biomet Manufacturing Corp
Orthopedic · 109d
Cleared Oct 02, 2015
Disposable Insulin Syringe
K151949 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 79d
Cleared Oct 02, 2015
Extended Range Shifter for PROBEAT-V
K152207 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 57d