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
37081–37104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · LCP
Beckman Coulter, Inc.
Chemistry · 104d
Cleared Jul 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 34d
Cleared Jul 14, 2014
CD HORIZON SPINAL SYSTEM
K141605 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 11, 2014
VIMOVE
K131094 · IKN
Dorsa VI Pty., Ltd.
Neurology · 449d
Cleared Jul 11, 2014
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
K131513 · GZJ
Ritm Okb Zao
Neurology · 409d
Cleared Jul 11, 2014
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
K132806 · GEX
Fotona D.D.
General & Plastic Surgery · 308d
Cleared Jul 11, 2014
ABX PENTRA MICRO ALB CONTROL L/H
K133676 · JJY
HORIBA ABX SAS
Chemistry · 224d
Cleared Jul 11, 2014
THE STORK OTC
K140186 · OBB
Rinovum Women'S Health, Inc.
Obstetrics & Gynecology · 168d
Cleared Jul 11, 2014
EXAMINATION GLOVES
K140316 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 151d
Cleared Jul 11, 2014
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP...
K140451 · HJO
Keeler Limited
Ophthalmic · 137d
Cleared Jul 11, 2014
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION...
K140459 · GEI
Conmed Corporation
General & Plastic Surgery · 137d
Cleared Jul 11, 2014
EXPRT REVISION KNEE
K140830 · JWH
Encore Medical, L.P.
Orthopedic · 100d
Cleared Jul 11, 2014
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
K140998 · MOS
Quality Electrodynamics, LLC
Radiology · 84d
Cleared Jul 11, 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
K141301 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d
Cleared Jul 11, 2014
REUSABLE GUIDE
K141334 · ITX
Koelis
Radiology · 51d
Cleared Jul 11, 2014
NEUROPACE BURR HOLE COVER
K141368 · GXR
NeuroPace, Inc.
Neurology · 49d
Cleared Jul 11, 2014
SYSTEM CALIBRATER
K141388 · JIX
Beckman Coulter Ireland, Inc.
Chemistry · 45d
Cleared Jul 11, 2014
MYLABSIX ULTRASOUND SYSTEM
K141486 · IYN
Esaote Europe B.V.
Radiology · 36d
Cleared Jul 11, 2014
INSTAFIX SHAPE MEMORY FIXATION SYSTEM
K141550 · JDR
Ot Medical
Orthopedic · 30d
Cleared Jul 11, 2014
ESIE APPS SUITE
K141554 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jul 11, 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
K141558 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 29d
Cleared Jul 11, 2014
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
K141582 · DPS
Welch Allyn
Cardiovascular · 28d
Cleared Jul 10, 2014
BLOSSOM SALINE DELIVERY ASSIST DEVICE
K131692 · LCJ
Marz Medical, Inc.
General & Plastic Surgery · 395d
Cleared Jul 10, 2014
GANTRY BEAM LINE
K132919 · LHN
Ion Beam Applications S.A.
Radiology · 296d