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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
77665–77688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2001
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
K011702 · NHI
Vertis Neuroscience, Inc.
Neurology · 203d
Cleared Dec 21, 2001
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
K011832 · NMF
Vanguard Medical Concepts, Inc.
Cardiovascular · 192d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · DQY
Boston Scientific Corp
Cardiovascular · 186d
Cleared Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953 · CGA
Wiener Laboratories Saic
Chemistry · 183d
Cleared Dec 21, 2001
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR...
K011960 · GEX
Lares Research, Inc.
General & Plastic Surgery · 182d
Cleared Dec 21, 2001
DIGIPAN / DPI
K012514 · MUH
Trophy Radiologie
Radiology · 137d
Cleared Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
K012569 · GXP
Biomet, Inc.
Neurology · 134d
Cleared Dec 21, 2001
GELCLAIR CONCENTRATED ORAL GEL
K013056 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 101d
Cleared Dec 21, 2001
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K013193 · GEX
Biolitec, Inc.
General & Plastic Surgery · 88d
Cleared Dec 21, 2001
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
K013371 · JJQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 71d
Cleared Dec 21, 2001
NORMATEC PCD
K013436 · JOW
Normatec, Inc.
Cardiovascular · 66d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466 · JHO
Helena Laboratories
Chemistry · 64d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · HTO
Synthes (Usa)
Orthopedic · 59d
Cleared Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · DHX
Bayer Corp.
Immunology · 56d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606 · LPS
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV
Diamedix Corp.
Immunology · 46d
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · CIC
Wiener Laboratories Saic
Chemistry · 45d
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013800 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 36d
Cleared Dec 21, 2001
GLO-SPEC
K013817 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 35d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · JIT
Diamond Diagnostics, Inc.
Chemistry · 31d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900 · JJX
Ortho-Clinical Diagnostics
Toxicology · 28d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 37d