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
46657–46680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2011
YOULASER CO2 LASER SYSTEM
K111592 · GEX
Quanta System Spa
General & Plastic Surgery · 79d
Cleared Aug 25, 2011
AQUILION LB MOVEMENT BASE KIT
K111633 · JAK
Toshiba America Medical Systems, In.C
Radiology · 73d
Cleared Aug 25, 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104 · JJX
Roche Diagnostics
Chemistry · 34d
Cleared Aug 25, 2011
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T...
K112112 · MOS
Sentinel Medical, Inc.
Radiology · 31d
Cleared Aug 24, 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511 · DTK
C.R. Bard, Inc.
Cardiovascular · 357d
Cleared Aug 24, 2011
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
K103706 · QYX
Applied Cardiac Systems, Inc.
Cardiovascular · 247d
Cleared Aug 24, 2011
LIFECARE CONDUCTIVE GARMENTS
K103719 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 246d
Cleared Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031 · GIR
Instrumentation Laboratory CO
Hematology · 231d
Cleared Aug 24, 2011
SHENGKUN CHEMICAL
K110621 · LYZ
Zibo Shengkun Chemical Industrial...
General Hospital · 174d
Cleared Aug 24, 2011
DIGITAL THERMOMETER MT SERIES
K110776 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 156d
Cleared Aug 24, 2011
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293 · KLW
Soundcure, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 24, 2011
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · OVE
K2m, Inc.
Orthopedic · 92d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Aug 24, 2011
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 83d
Cleared Aug 24, 2011
ECG SERIES ELECTROCARDIOGRAPH
K111805 · DPS
Advanced Instrumentations, Inc.
Cardiovascular · 58d
Cleared Aug 24, 2011
NUVANT, MOBILE CARDIAC TELEMETRY
K111917 · QYX
Corventis, Inc.
Cardiovascular · 49d
Cleared Aug 24, 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 34d
Cleared Aug 23, 2011
DEKA TAC DEVICE
K093915 · FIG
Deka Research & Development Corp.
Gastroenterology & Urology · 609d
Cleared Aug 23, 2011
PASS ANTERIOR SPINAL SYSTEM
K102406 · KWQ
Medicrea Technologies
Orthopedic · 364d
Cleared Aug 23, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K110016 · LYZ
Rongyao Plastic Produce Co., Ltd.
General Hospital · 232d
Cleared Aug 23, 2011
DDRELEMENT
K110828 · KPR
Swissray Medical AG
Radiology · 152d
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K111072 · OPL
Bio-Rad Laboratories
Microbiology · 127d
Cleared Aug 23, 2011
RESPIRE BLUE SERIES
K111207 · LRK
Respire Medical
Dental · 116d
Cleared Aug 23, 2011
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
K111373 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 99d