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
146497–146520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1985
ROTEX SCREW BIOPSY NEEDLE
K854404 · FCG
Meadox Surgimed, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 02, 1985
MALIS IRRIGATION SYSTEM
K854413 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 28d
Cleared Dec 02, 1985
VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON
K854497 · IOR
Canadian Wheelchair
Physical Medicine · 20d
Cleared Dec 02, 1985
TUBING CLAMP CAT#1000-A
K854512 · FKK
Rao Medical Devices, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 02, 1985
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
K854517 · FKK
Travenol Laboratories, S.A.
Gastroenterology & Urology · 20d
Cleared Dec 02, 1985
BLADE, SCALPEL
K854561 · GES
Medelec Intl. Corp.
General & Plastic Surgery · 18d
Cleared Dec 02, 1985
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
K854568 · GEF
American V. Mueller
General & Plastic Surgery · 18d
Cleared Dec 02, 1985
MODIFIED AM-SERIES DIALYZERS
K854575 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Nov 29, 1985
EDEC 2000
K852908 · IZO
Electromed Intl., Ltd.
Radiology · 143d
Cleared Nov 29, 1985
PO-510 TCPO2 MONITOR
K852959 · KLK
Sumitomo Electric Industries, Inc.
Anesthesiology · 140d
Cleared Nov 29, 1985
ELF
K853433 · BTY
Cardio-Respiratory
Anesthesiology · 106d
Cleared Nov 29, 1985
IN A WINK LUBRICATING & REWETTING DROPS
K853445 · HPX
Ciba Vision Care
Ophthalmic · 105d
Cleared Nov 29, 1985
PENOX HIGH FLOW MANIFOLD
K853775 · BYJ
Penox Technologies, Inc.
Anesthesiology · 80d
Cleared Nov 27, 1985
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
K850683 · DEB
Kent Laboratories, Inc.
Immunology · 279d
Cleared Nov 27, 1985
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190 · GWN
Nicolet Biomedical Instruments
Neurology · 246d
Cleared Nov 27, 1985
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
K854049 · JXG
American V. Mueller
Neurology · 55d
Cleared Nov 27, 1985
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · JXG
Cordis Corp.
Neurology · 20d
Cleared Nov 27, 1985
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR
K854599 · CCL
Vickers , Ltd.
Anesthesiology · 9d
Cleared Nov 26, 1985
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · GQN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 494d
Cleared Nov 26, 1985
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149 · JAF
Keymed, Inc.
Radiology · 250d
Cleared Nov 26, 1985
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
K852704 · HGM
Clincal Instruments Corp.
Obstetrics & Gynecology · 153d
Cleared Nov 26, 1985
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 92d
Cleared Nov 26, 1985
SYS*STIM 207 MODEL ME 207
K853750 · IPF
Mettler Electronics Corp.
Physical Medicine · 78d
Cleared Nov 26, 1985
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
K853755 · ITX
Victoreen, Inc.
Radiology · 78d