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
38161–38184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2014
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
K140318 · OBJ
Biosense Webster
Cardiovascular · 30d
Cleared Mar 12, 2014
TORRENT IRRIGATION SYSTEM
K140405 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 2014
NOVEON
K122358 · GEX
Hogan Lovells US LLP
General & Plastic Surgery · 585d
Cleared Mar 11, 2014
ISYS 1 (U.S),ACCESSORY, NON-STERILE
K131433 · JAK
Isys Medizintechnik GmbH
Radiology · 298d
Cleared Mar 11, 2014
BPROSOFT CASP PC SOFTWARE
K131916 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 258d
Cleared Mar 11, 2014
CIOS ALPHA
K132094 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 246d
Cleared Mar 11, 2014
NEWTRON P5 XS B.LED
K132322 · ELC
Satelec - Acteon Group
Dental · 229d
Cleared Mar 11, 2014
ACCURO 3000 ULTRASOUND SCANNER
K132736 · IYO
Rivanna Medical, LLC
Radiology · 189d
Cleared Mar 11, 2014
REVERE STABILIZATION SYSTEM
K133350 · NKB
Globus Medical, Inc.
Orthopedic · 132d
Cleared Mar 11, 2014
OVATION TRIBUTE HIP STEM
K133386 · LPH
Ortho Development Corp.
Orthopedic · 126d
Cleared Mar 11, 2014
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
K133401 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Carestream Health, Inc.
Radiology · 119d
Cleared Mar 11, 2014
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR...
K133483 · IRP
Portable Therapeutix
Physical Medicine · 118d
Cleared Mar 11, 2014
KOWA SL-17
K133755 · HJO
Kowa Co. , Ltd.
Ophthalmic · 92d
Cleared Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · KHS
Hitachi Chemical Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 11, 2014
ULTIMUM EV HEMOSTASIS INTRODUCER
K140327 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Mar 10, 2014
BIOFUSIONARY BEBE
K121123 · IMJ
Rocky Mountain Biosystems, Inc.
Physical Medicine · 696d
Cleared Mar 10, 2014
T4/T5 HYTREL TOGAS
K121664 · FYA
Stryker Corporation
General Hospital · 643d
Cleared Mar 10, 2014
MM-SEAL
K123276 · KIF
Micro-Mega Societe Anonyme
Dental · 507d
Cleared Mar 10, 2014
BWCSH-1 SHARPS CONTAINER
K131708 · MMK
Bradford Wright Companies, Inc.
General Hospital · 272d
Cleared Mar 10, 2014
NEWTRON P5, NEWTRON P5 B.LED
K132267 · ELC
Satelec - Acteon Group
Dental · 231d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Mar 10, 2014
VAN HIP FRACTURE SYSTEM
K133104 · HSB
Epix Orthopaedic, Corp.
Orthopedic · 161d
Cleared Mar 10, 2014
IMPACT MODEL 323 ASPIRATOR
K133196 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 144d