FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122881–122904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · HSD
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
K905606 · HGM
Atheus Corp.
Obstetrics & Gynecology · 88d
Cleared Mar 12, 1991
KODAK X-OMAT MULTILOADER 300
K905607 · IXW
Eastman Kodak Company
Radiology · 88d
Cleared Mar 12, 1991
SEMINOR
K905764 · MFD
Promedex, Inc.
Obstetrics & Gynecology · 75d
Cleared Mar 12, 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 75d
Cleared Mar 12, 1991
Q SYSTEM 28 HIP STEM
K910010 · LWJ
Turnkey Intergration USA, Inc.
Orthopedic · 69d
Cleared Mar 12, 1991
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082 · DGC
Quidel Corp.
Immunology · 63d
Cleared Mar 12, 1991
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · BWF
Monaghan Medical Corp.
Anesthesiology · 57d
Cleared Mar 12, 1991
SUNGLASSES
K910329 · HOI
Cutler & Gross Sloan Optical , Ltd.
Ophthalmic · 46d
Cleared Mar 12, 1991
BIODEGRADABLE SURGICAL STAPLE
K910723 · JDR
Instrument Makar, Inc.
Orthopedic · 20d
Cleared Mar 11, 1991
CHEMA CHOL CHOLESTEROL SYSTEM
K904031 · CHH
Texas Intl. Laboratories, Inc.
Chemistry · 192d
Cleared Mar 11, 1991
GLUCOSE (HK) REAGENT, UNIVERSAL
K905227 · CFR
Enzyme Technology, Inc.
Chemistry · 111d
Cleared Mar 11, 1991
ANTIGENZ CHLAMYDIA
K905402 · GZB
Northumbria Biologicals , Ltd.
Microbiology · 98d
Cleared Mar 11, 1991
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 94d
Cleared Mar 11, 1991
LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
K905542 · EFB
Lares Research, Inc.
Dental · 90d
Cleared Mar 11, 1991
LARES APOLLO CS/CP/C
K905543 · EBZ
Lares Research, Inc.
Dental · 90d
Cleared Mar 11, 1991
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
K905596 · GZB
Neuromed, Inc.
Neurology · 88d
Cleared Mar 11, 1991
BIOTROL LACTATE DEHYDROGENASE (L-P)
K905683 · CFJ
Biotrol, USA, Inc.
Chemistry · 82d
Cleared Mar 11, 1991
SIEMENS ETCO2 CARTRIDGE
K905775 · CCK
Siemens Medical Electronics
Anesthesiology · 74d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Mar 11, 1991
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED
K910147 · CGX
Olympus Corp.
Chemistry · 56d
Cleared Mar 11, 1991
HEMOCARD CONTROL
K910431 · JCM
Isolab, Inc.
Hematology · 38d
Cleared Mar 11, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K910484 · JWY
Alamar
Microbiology · 33d
Cleared Mar 11, 1991
LOOP RETRIEVER
K910603 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 27d