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

Filters: Cleared only ×
175,820 results
35809–35832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · MSV
Inova Diagnostics, Inc.
Immunology · 273d
Cleared Feb 13, 2015
COGNISION EEG/EP SYSTEM
K141316 · OLT
Neuronetrix Solutions
Neurology · 269d
Cleared Feb 13, 2015
ELIA M2
K141375 · DBM
Phadia US, Inc.
Immunology · 262d
Cleared Feb 13, 2015
DIGITAL ELECTROCARDIOGRAPH
K141946 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 211d
Cleared Feb 13, 2015
GALILEO NT
K142064 · OLT
Eb Neuro S.P.A.
Neurology · 198d
Cleared Feb 13, 2015
SEEGENE ANYPLEX II HSV-1/2 ASSAY
K142156 · OQO
Seegene
Microbiology · 191d
Cleared Feb 13, 2015
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with...
K142298 · JOH
Covidien
Anesthesiology · 179d
Cleared Feb 13, 2015
ivWatch Model 400
K142374 · MRZ
Ivwatch, LLC
General Hospital · 171d
Cleared Feb 13, 2015
Neuwater TM (HydrocynTM aqua)
K142775 · FRO
Vigilenz Medical Devices
General & Plastic Surgery · 140d
Cleared Feb 13, 2015
DMRC Dual Cure Orthodontic Band Cement
K142881 · DYH
Danville Materials, LLC
Dental · 134d
Cleared Feb 13, 2015
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
K142924 · GEX
Shaser, Inc.
General & Plastic Surgery · 128d
Cleared Feb 13, 2015
PuraDerm Gel
K143058 · FRO
3-D Matrix, Inc.
General & Plastic Surgery · 112d
Cleared Feb 13, 2015
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
K143127 · CCK
Dispo-Med (Malaysia) Sdn Bhd
Anesthesiology · 105d
Cleared Feb 13, 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 80d
Cleared Feb 13, 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic)...
K143632 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared Feb 13, 2015
TOMTEC-ARENA TTA2
K150122 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 24d
Cleared Feb 12, 2015
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR...
K133268 · EBG
Schutz-Dental GmbH
Dental · 476d
Cleared Feb 12, 2015
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
K134046 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 408d
Cleared Feb 12, 2015
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
K140900 · KRO
Stanmore Worldwide Implants , Ltd.
Orthopedic · 310d
Cleared Feb 12, 2015
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K141087 · CAH
Intersurgical Incorporated
General Hospital · 290d
Cleared Feb 12, 2015
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
K141222 · NKB
Life Spine, Inc.
Orthopedic · 276d
Cleared Feb 12, 2015
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
K141328 · LLL
Inova Diagnostics, Inc.
Immunology · 267d
Cleared Feb 12, 2015
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
K141803 · DJG
Immunalysis Corporation
Toxicology · 224d
Cleared Feb 12, 2015
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape,...
K143055 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 112d