FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72169–72192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2003
KAVO EVEREST TITANBLANK
K024214 · EJH
Kavo America
Dental · 82d
Cleared Mar 12, 2003
MSI TA ELECTRODES
K024266 · GEI
Medsphere International, Inc.
General & Plastic Surgery · 79d
Cleared Mar 12, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024335 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Mar 12, 2003
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036 · DYH
Pulpdent Corporation
Dental · 68d
Cleared Mar 12, 2003
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL...
K030038 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 65d
Cleared Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · KXK
Varian Medical Systems
Radiology · 2d
Cleared Mar 11, 2003
OPTIDOS
K010705 · KXK
Ptw-New York Corp.
Radiology · 732d
Cleared Mar 11, 2003
IMBIBE BONE MARROW ASPIRATION SYRINGE
K023074 · FMF
Orthovita, Inc.
General Hospital · 176d
Cleared Mar 11, 2003
TRACERS BONE CEMENT OPACIFIER
K023445 · MYU
Parallax Medical, Inc.
Neurology · 147d
Cleared Mar 11, 2003
OSSE-LIGN
K023564 · JDQ
Osseus, LLC
Orthopedic · 139d
Cleared Mar 11, 2003
CCD CAMERA, MODEL PKP-06000-000
K024085 · IZJ
Perkins Electronics Co.
Radiology · 90d
Cleared Mar 11, 2003
REPROCESSED COMPRESSION SLEEVES
K024087 · JOW
Alliance Medical Corp.
Cardiovascular · 90d
Cleared Mar 11, 2003
VACUFLASH BIOPSY SYSTEM
K024089 · KNW
Bip USA, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 11, 2003
VICTOREEN THEBES II, MODEL 7020
K024284 · IYE
Syncor Radiation Management
Radiology · 78d
Cleared Mar 11, 2003
RAPID PROGRAMMAR
K030118 · GZB
Advanced Neuromodulation Systems
Neurology · 57d
Cleared Mar 11, 2003
ENDOS AC/ACP
K030185 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 49d
Cleared Mar 11, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-890
K030387 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 34d
Cleared Mar 11, 2003
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
K030476 · DQY
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Mar 11, 2003
MODIFICATION TO VNUS CLOSURE SYSTEM
K030557 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Mar 10, 2003
LIFESTENT BILIARY ENDOPROSTHESIS
K023121 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 172d
Cleared Mar 10, 2003
KENDRO HERACELL 240 INCUBATOR
K023465 · MQG
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 146d
Cleared Mar 10, 2003
IRRIGATION SETS
K023808 · LJH
International Medsurg Connection
Gastroenterology & Urology · 116d
Cleared Mar 10, 2003
DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
K024077 · DXN
Zewa, Inc.
Cardiovascular · 90d
Cleared Mar 10, 2003
AIGIS-PLUS
K024135 · EJT
Sb Lucius, Inc.
Dental · 84d