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
138385–138408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1987
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS
K871878 · LSK
Gen-Probe, Inc.
Microbiology · 167d
Cleared Oct 28, 1987
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · JJF
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Oct 28, 1987
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
K872379 · JWH
Zimmer, Inc.
Orthopedic · 131d
Cleared Oct 28, 1987
MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT
K872986 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 89d
Cleared Oct 28, 1987
ENTERIC ISOLATION MEDIA
K873261 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
DIFFERENTIAL MEDIA
K873262 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA
K873263 · JSH
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS
K873264 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION
K873265 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MIDDLEBROOK BASED MEDIA
K873266 · KZI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
CARBAMAZEPINE (FPIA) CALIBRATOR KIT
K873281 · DLJ
Windsor Laboratories, Inc.
Toxicology · 72d
Cleared Oct 28, 1987
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377 · GBS
Gish Biomedical, Inc.
General & Plastic Surgery · 65d
Cleared Oct 28, 1987
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · MBV
Protek, Inc.
Orthopedic · 64d
Cleared Oct 28, 1987
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
K873459 · KTT
Howmedica Corp.
Orthopedic · 61d
Cleared Oct 28, 1987
POROUS COATED ACETABULAR CUP
K873585 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 54d
Cleared Oct 28, 1987
BONE PIN CUTTER 18
K873715 · HXZ
Military Engineering, Inc.
Orthopedic · 43d
Cleared Oct 28, 1987
IOI BIPOLAR PROSTHESIS
K873815 · KWY
Intermedics Orthopedics
Orthopedic · 37d
Cleared Oct 28, 1987
ALTAIREX BUCKY/CASSETTE TRAY COMBINATION
K873849 · IXQ
Altairex Manufacturing, Inc.
Radiology · 36d
Cleared Oct 28, 1987
EMIT GENTAMICIN ASSAY
K873854 · LCD
Syva Co.
Toxicology · 36d
Cleared Oct 28, 1987
HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013
K873872 · DHA
Medix Biotech, Inc.
Chemistry · 36d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899 · DJR
Syva Co.
Toxicology · 34d
Cleared Oct 28, 1987
READING CHARTS-CARDS (DISTANCE AND NEARPOINT)
K873909 · HOX
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
JACKSON CROSS CYLINDER TEST
K873915 · HOR
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
HEAD & CHIN RESTS
K873918 · HRH
Richmond Products, Inc.
Ophthalmic · 34d