Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37657–37680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K141566 · MQB
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 15, 2014
HEARTWAY POWER WHEELCHAIR
K132856 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 306d
Cleared Jul 15, 2014
MILESTONE SPINAL SYSTEM
K133053 · MAX
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 291d
Cleared Jul 15, 2014
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
K133813 · MAX
Expanding Orthopedics, Inc.
Orthopedic · 211d
Cleared Jul 15, 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · GAW
Aesculap, Inc.
General & Plastic Surgery · 207d
Cleared CT Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K140615 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 127d
Cleared Jul 15, 2014
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · OCX
Medivators
Gastroenterology & Urology · 111d
Cleared Jul 15, 2014
CORMATRIX ECM FOR VASCULAR REPAIR
K140789 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 106d
Cleared Jul 15, 2014
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · JOW
Covidien
Cardiovascular · 105d
Cleared Jul 15, 2014
GMK SPHERE EXTENSION
K140826 · JWH
Medacta International
Orthopedic · 105d
Cleared Jul 15, 2014
LINSCAN 808, LINSCAN 980
K141063 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 82d
Cleared Jul 15, 2014
PULSTAR LOGIX PUMP
K141609 · JOW
Albahealth, LLC
Cardiovascular · 29d
Cleared Jul 14, 2014
PFX SPINOUS PROCESS FIXATION SYSTEM
K132765 · PEK
Innovasis, Inc.
Orthopedic · 313d
Cleared Jul 14, 2014
CONSENSUS VITALITE TIBIAL INSERT
K133919 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 203d
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 CT 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