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
152305–152328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1984
DOPPLER IMAGING OPTION
K840140 · IYN
Hewlett-Packard Co.
Radiology · 232d
Cleared Aug 23, 1984
BETA SCAN DRYSTIX
K841369 · CGA
Orange Medical Instruments, Inc.
Chemistry · 142d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E31V
K842073 · ESD
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E30V
K842074 · ESD
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 23, 1984
AUGMENTIN 30 MCG SENSI DISC
K842253 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Aug 23, 1984
BEHING THE EAR HEARING AID T-98
K842434 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 64d
Cleared Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · JHI
Hybritech, Inc.
Chemistry · 45d
Cleared Aug 23, 1984
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839 · GTQ
Analytical Products, Inc.
Immunology · 34d
Cleared Aug 23, 1984
SUPER MAXITHINS BODY-SHAPED MAXI PADS
K842950 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 23, 1984
MAXITHINS BODY-SHAPED PANTY SHIELDS
K842951 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 23, 1984
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · JOP
Hewlett-Packard Co.
Cardiovascular · 3d
Cleared Aug 22, 1984
ULTRA SHAPE CONDOMS
K833365 · HIS
Barnetts, Inc.
Obstetrics & Gynecology · 330d
Cleared Aug 22, 1984
NOVA 12 CARDIAC OUTPUT COMPUTER
K840009 · DXG
Nova Medical Specialties
Cardiovascular · 231d
Cleared Aug 22, 1984
DYNASCOPE SERIES
K840055 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 229d
Cleared Aug 22, 1984
BETA-HCG HEMAGGLUTINATION TEST
K842181 · JHJ
Sero-Immuno Diagnostics, Inc.
Chemistry · 82d
Cleared Aug 22, 1984
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT
K842752 · JXR
The Perkin-Elmer Corp.
Toxicology · 37d
Cleared Aug 22, 1984
QCA TRIGLYCERIDES
K842891 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Aug 22, 1984
REGULAR MAXITHINS BODY-SHAPED MAXI
K842952 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 22, 1984
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · CAW
Puritan Bennett Corp.
Anesthesiology · 368d
Cleared Aug 21, 1984
MICRO DELTA & CELTAPRO
K841964 · IYX
Computer Design & Applications, Inc.
Radiology · 99d
Cleared Aug 21, 1984
ADP NDNA IFA TEST
K842707 · KTL
Apple Diagnostic Products
Immunology · 40d
Cleared Aug 21, 1984
INTERFERENZ 4
K842803 · IPF
Robert Bosch Corp.
Physical Medicine · 35d
Cleared Aug 21, 1984
DIADYN 4
K842804 · IPF
Robert Bosch Corp.
Physical Medicine · 35d
Cleared Aug 21, 1984
PRO-PAR CLEARANT
K842861 · KEM
Anatech, Ltd.
Pathology · 29d