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
38977–39000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 338d
Cleared Dec 06, 2013
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR...
K130669 · GEI
Olsen Medical
General & Plastic Surgery · 269d
Cleared Dec 06, 2013
ANESTHESIA CONDUCTION NEEDLES
K131006 · BSP
Lccs Products Limited
Anesthesiology · 239d
Cleared Dec 06, 2013
HEART SYNC
K131550 · MKJ
Heart Sync, Inc.
Cardiovascular · 191d
Cleared Dec 06, 2013
K SERIES CPAP SYSTEMS
K131702 · BZD
Curative Medical, Inc.
Anesthesiology · 178d
Cleared Dec 06, 2013
OSTEOMED NEURO RONGEUR
K131851 · HAE
Osteomed
Neurology · 168d
Cleared Dec 06, 2013
FAMILY OF COOLGLIDE AESTHETIC LASERS
K132185 · GEX
Cutera, Inc.
General & Plastic Surgery · 144d
Cleared Dec 06, 2013
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202 · LGZ
Enthermics Medical Systems, Inc.
General Hospital · 143d
Cleared Dec 06, 2013
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · DZE
Cowellmedi Co., Ltd.
Dental · 141d
Cleared Dec 06, 2013
CD HORIZON SPINAL SYSTEM
K132328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 06, 2013
LIGAPASS
K132395 · OWI
Medicrea International
Orthopedic · 127d
Cleared Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA...
K132429 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 06, 2013
PIEZON 250
K132445 · ELC
E.M.S Electro Medical Systems S.A
Dental · 122d
Cleared Dec 06, 2013
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
K132519 · JEY
Stryker
Dental · 116d
Cleared Dec 06, 2013
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
K132967 · BZD
3B Medical, Inc.
Anesthesiology · 77d
Cleared Dec 06, 2013
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
K133029 · DXC
Compression Works, LLC
Cardiovascular · 71d
Cleared Dec 06, 2013
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K133043 · LIT
Angioslide, Ltd.
Cardiovascular · 71d
Cleared Dec 06, 2013
STAXX(R) SYSTEM
K133207 · MQP
Spine Wave, Inc.
Orthopedic · 49d
Cleared Dec 06, 2013
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · GAW
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Dec 06, 2013
CROSSTREES PVA POD
K133372 · NDN
Crosstrees Medical, Inc.
Orthopedic · 35d
Cleared Dec 05, 2013
BOND APATITE
K121177 · LYC
Augma Biomaterials, Ltd.
Dental · 596d
Cleared Dec 05, 2013
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K130467 · MBI
MedShape, Inc.
Orthopedic · 283d
Cleared Dec 05, 2013
CAPELLA
K130788 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 258d
Cleared Dec 05, 2013
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
K131095 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 231d