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
74089–74112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2002
UNIVERSAL CMF SYSTEM
K022185 · JEY
Stryker Instruments
Dental · 167d
Cleared Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA...
K022288 · LTJ
Bayer Corp.
Immunology · 155d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · CDZ
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · HQF
Quantel Medical
Ophthalmic · 90d
Cleared Dec 17, 2002
PROSOLV CARDIVASCULAR VIEWER
K023112 · DQK
Problem Solving Concepts, Inc.
Cardiovascular · 89d
Cleared Dec 17, 2002
JOSTRA MECC SYSTEM
K023132 · KFM
Jostra AG
Cardiovascular · 88d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 17, 2002
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
K023185 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 84d
Cleared Dec 17, 2002
STERI-SPOUTS
K023539 · LHI
Valumed
General Hospital · 56d
Cleared Dec 17, 2002
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
K023560 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 55d
Cleared Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
K023867 · JJY
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · GEI
Arthrex, Inc.
General & Plastic Surgery · 15d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482 · HNO
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
K021699 · LYL
Autolens, Inc.
Ophthalmic · 208d
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · JHI
Sa Scientific, Inc.
Chemistry · 126d
Cleared Dec 16, 2002
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000,...
K022762 · DQX
Jomed, Inc.
Cardiovascular · 118d
Cleared Dec 16, 2002
PREG-Q EARLY PREGNANCY TEST
K023027 · LCX
Yd Diagnostics
Chemistry · 96d
Cleared Dec 16, 2002
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
K023081 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 16, 2002
GELSPHERES EMBOLIC AGENT
K023089 · HCG
Biocure, Inc.
Neurology · 90d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
K023101 · LAF
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN AMPHETAMINE TEST
K023104 · DKZ
Amedica Biotech, Inc.
Toxicology · 89d