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
40417–40440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2013
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K131445 · HRS
Osteomed LP
Orthopedic · 29d
Cleared Jun 17, 2013
STELLAR 150
K122715 · MNT
Resmed Germany, Inc.
Anesthesiology · 285d
Cleared Jun 17, 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809 · DKZ
Advin Biotech
Toxicology · 277d
Cleared Jun 17, 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II...
K123431 · LPL
Dreamcon Co., Ltd.
Ophthalmic · 222d
Cleared Jun 17, 2013
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
K123590 · LYZ
Weilin Plastic and Rubber Products...
General Hospital · 208d
Cleared Jun 17, 2013
SOFIA STREP A FIA
K123793 · GTY
Quidel Corporation
Microbiology · 189d
Cleared Jun 17, 2013
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · GXR
Biomet Microfixation
Neurology · 130d
Cleared Jun 17, 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · KRD
MicroVention, Inc.
Cardiovascular · 104d
Cleared Jun 15, 2013
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
K130414 · LIT
Trireme Medical, Inc.
Cardiovascular · 116d
Cleared Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE...
K121214 · MMI
Beckman Coulter, Inc.
Chemistry · 417d
Cleared Jun 14, 2013
CHABNER XRT GARMENTS
K121284 · IYE
Chabner Xrt, LLC
Radiology · 410d
Cleared Jun 14, 2013
MODULAP LOOP
K121343 · KNF
Atc Technologies, Inc.
Obstetrics & Gynecology · 406d
Cleared Jun 14, 2013
BEL-GEN COLD STORAGE SOLUTION
K121618 · KDL
Waters Medical Systems, LLC
Gastroenterology & Urology · 378d
Cleared Jun 14, 2013
PROVITEMP
K122551 · EMA
Itena Clinical
Dental · 297d
Cleared Jun 14, 2013
LASER HELMET
K122950 · OAP
Theradome, Inc.
General & Plastic Surgery · 262d
Cleared Jun 14, 2013
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
K123127 · JJX
Maine Standards Co.
Immunology · 253d
Cleared Jun 14, 2013
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 185d
Cleared Jun 14, 2013
AMIA AUTOMATED PD SYSTEM
K124018 · FKX
Deka Research & Development Corp.
Gastroenterology & Urology · 169d
Cleared Jun 14, 2013
FRAXEL DUAL 1550/1927 LASER SYSTEM
K130193 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 140d
Cleared Jun 14, 2013
I-MAX TOUCH 3D
K130443 · OAS
Owandy
Radiology · 113d
Cleared Jun 14, 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K130542 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 105d
Cleared Jun 14, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130801 · IYN
Sonoscape Company Limited
Radiology · 84d
Cleared Jun 14, 2013
INTELLIVUE PATIENT MONITOR MX400
K130849 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 80d
Cleared Jun 14, 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 78d