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
39577–39600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2013
NMI COAXIAL MICROINTRODUCER SET
K132713 · DRE
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · NQN
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · NBW
Bayer Healthcare
Chemistry · 416d
Cleared Sep 26, 2013
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K124043 · HQF
Lightmed Corp.
Ophthalmic · 272d
Cleared Sep 26, 2013
TCM MASSAGER
K130150 · NUH
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
Neurology · 247d
Cleared Sep 26, 2013
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
K130275 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 234d
Cleared Sep 26, 2013
PRECISION ONE LIFECARE
K130952 · MNW
Precision One Lifecare, Ltd.
Gastroenterology & Urology · 174d
Cleared Sep 26, 2013
GENII ARC SMART ARGON PROBE
K130983 · GEI
Genii, Inc.
General & Plastic Surgery · 170d
Cleared Sep 26, 2013
TRANSCEND HEATED HUMIDIFIER
K131388 · BTT
Somnetics International, Inc.
Anesthesiology · 135d
Cleared Sep 26, 2013
COSEAL
K131411 · DXC
Jilin Coronado Medical , Ltd.
Cardiovascular · 134d
Cleared Sep 26, 2013
AIRO CT SYSTEM
K131431 · JAK
Mobius Imaging, LLC
Radiology · 132d
Cleared Sep 26, 2013
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
K131795 · IYE
Orfit Industries NV
Radiology · 100d
Cleared Sep 26, 2013
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · MUE
GE Medical Systems SCS
Radiology · 93d
Cleared Sep 26, 2013
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · DPS
Philips Medical Systems
Cardiovascular · 85d
Cleared Sep 26, 2013
PROTURA COUCH SOFTWARE
K132084 · JAI
Med-Tec, Inc. D/B/A Civco Medical...
Radiology · 83d
Cleared Sep 26, 2013
ESTEYA
K132092 · JAD
Nucletron B.V.
Radiology · 83d
Cleared Sep 26, 2013
CG+ ARROW JACC POWERED BY ARROW VPS STYLET
K132133 · OBJ
Arrow International (Subsidiary of...
Cardiovascular · 77d
Cleared Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · LXB
Cochlear Americas
Ear, Nose, Throat · 65d
Cleared Sep 26, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K132654 · IYO
Siemens Medical Solutions USA, Inc....
Radiology · 31d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 26, 2013
PRIMI SUPPORT CATHETER
K132701 · DQY
Thermopeutix, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · LIT
Ev3, Inc.
Cardiovascular · 21d
Cleared Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS...
K121790 · MMI
Beckman Coulter, Inc.
Chemistry · 464d
Cleared Sep 25, 2013
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
K130455 · EFB
Dentalez Group, Stardental Division
Dental · 215d