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
37681–37704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 10, 2014
MARATHON NO STING LIQUID SKIN PROTECTANT
K133443 · KMF
Advanced Medical Solutions...
General & Plastic Surgery · 240d
Cleared Jul 10, 2014
VERADIUS
K133819 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 206d
Cleared Jul 10, 2014
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
K140101 · GCJ
Ab Medica Sas
General & Plastic Surgery · 176d
Cleared Jul 10, 2014
MELUNA CLASSIC/SPORT MENSTRUAL CUP
K140626 · HHE
Meluna
Obstetrics & Gynecology · 121d
Cleared Jul 10, 2014
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
K140658 · GEI
Conmed Corporation
General & Plastic Surgery · 118d
Cleared Jul 10, 2014
RANGE/MESA/DENALI SPINAL SYSTEM
K140765 · NKB
K2m, Inc.
Orthopedic · 105d
Cleared Jul 10, 2014
ENADEN FLOW
K140976 · EBF
Km Corporation
Dental · 85d
Cleared Jul 10, 2014
3D EPTFE
K141027 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 79d
Cleared Jul 09, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K134005 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Jul 09, 2014
FLENTS PLASTIC EYE WASH CUP
K140409 · LXQ
Apothecary Products, Inc.
Ophthalmic · 141d