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

Filters: Cleared only ×
176,076 results
153193–153216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1984
ENTEROSCOPE
K840722 · FDA
Trimedyne, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 07, 1984
TRANSPORTER VIRAL TRANSPORT MEDIUM
K840744 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 105d
Cleared Jun 07, 1984
V.D.T.-GONORRHEA TEST KIT
K840799 · LIO
M.G. Laboratories, Inc.
Microbiology · 105d
Cleared Jun 07, 1984
ANTIMICROBIAL INCISE DRAPE
K840957 · KKX
American Convertors Div., American...
General Hospital · 93d
Cleared Jun 07, 1984
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · CAD
Siemens Elema AB
Anesthesiology · 80d
Cleared Jun 07, 1984
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174 · GOL
Intl. Diagnostic Technology
Microbiology · 80d
Cleared Jun 07, 1984
GLATTELAST COMPRESSION STOCKINGS
K841215 · DWL
Baurs Krey Assoc., Inc.
General Hospital · 77d
Cleared Jun 07, 1984
KMA-1300F
K841370 · BSZ
Medimex, Inc.
Anesthesiology · 65d
Cleared Jun 07, 1984
NEUROPACK 8 MEE 4108
K841497 · GWK
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Jun 07, 1984
NEUROPACK II 5100
K841612 · GWL
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Jun 07, 1984
ENTERAL NUTRITION PUMP
K841630 · FRN
Superior Plastic Products Corp.
General Hospital · 49d
Cleared Jun 07, 1984
MAST LUMINESCENT ALLERGY SYS
K841642 · DGC
Mast Immunosystems
Immunology · 48d
Cleared Jun 07, 1984
DRIGALSKI LITMUS LACTOSE AGAR
K841659 · JSF
Oxoid U.S.A., Inc.
Microbiology · 45d
Cleared Jun 07, 1984
MAXIMUM RECOVERY DILUENT
K841662 · JSG
Oxoid U.S.A., Inc.
Microbiology · 45d
Cleared Jun 07, 1984
Q.P. PREAMPLIFIER SYS
K841683 · GWQ
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
BIO/SCAN BIOLOG CASSETTE RECORDER
K841684 · GWQ
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
EEG ELECTRODES
K841685 · GXY
Bio-Scan, Inc.
Neurology · 45d
Cleared Jun 07, 1984
DEMAND C02
K841726 · KHS
Cooper Biomedical, Inc.
Chemistry · 43d
Cleared Jun 07, 1984
UROLOGICAL CATHETER & ACCESSORIES
K841727 · KOD
Research Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 07, 1984
MANNITOL SALT AGAR
K841747 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
XYLOSE-LYSINE DESOXYCHOLATE AGAR
K841752 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
MACCONKEY AGAR
K841753 · JSI
The Montana Deaconess Medical Center
Microbiology · 41d
Cleared Jun 07, 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · FRN
Abbott Laboratories
General Hospital · 38d
Cleared Jun 07, 1984
COOPER LASERSONICS ND:YAG LASER 8000
K841793
Cooper Lasersonics, Inc.
Cardiovascular · 38d