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
64873–64896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2005
COBRA SURGICAL SYSTEM
K051749 · GEI
Estech, Inc.
General & Plastic Surgery · 76d
Cleared Sep 13, 2005
BD PEN NEEDLE
K051899 · FMI
Becton, Dickinson & CO
General Hospital · 62d
Cleared Sep 13, 2005
SURGEON'S GLOVE, POWDER FREE
K052030 · KGO
Shun Thai Rubber Gloves Industry...
General Hospital · 48d
Cleared Sep 13, 2005
ACCORDION
K052048 · FFL
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 46d
Cleared Sep 13, 2005
B-BOP PLATE
K052152 · HRS
New Deal, S.A.
Orthopedic · 36d
Cleared Sep 13, 2005
PRE-POWDERED STERILE EXAM GLOVES
K052214 · LYY
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 29d
Cleared Sep 13, 2005
CRONO SUPER PID
K052217 · FRN
Cane S.R.L.
General Hospital · 29d
Cleared Sep 13, 2005
CRONO GO.
K052219 · FRN
Cane S.R.L.
General Hospital · 29d
Cleared Sep 12, 2005
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W,...
K051565 · DXN
Proton Healthcare , Ltd.
Cardiovascular · 90d
Cleared Sep 12, 2005
ANGIODYNAMICS, INC., MICRO ACCESS KITS
K051655 · DQR
AngioDynamics, Inc.
Cardiovascular · 83d
Cleared Sep 12, 2005
COGNITRACE
K051825 · GWQ
Eemagine Medical Imaging Solutions GmbH
Neurology · 69d
Cleared Sep 12, 2005
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
K052015 · DLJ
Dade Behring, Inc.
Toxicology · 48d
Cleared Sep 12, 2005
POWDERED LATEX SURGEON'S GLOVE
K052031 · KGO
Shun Thai Rubber Gloves Industry...
General Hospital · 47d
Cleared Sep 12, 2005
CAPIOX AF125X ARTERIAL FILTER
K052205 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 31d
Cleared Sep 12, 2005
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
K052224 · LSL
Becton, Dickinson & CO
Microbiology · 27d
Cleared Sep 12, 2005
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302 · MAL
Boston Scientific Corp
Cardiovascular · 19d
Cleared Sep 09, 2005
SPINA SYSTEM
K033231 · ITH
North American Medical Corp (Nam)
Physical Medicine · 704d
Cleared Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · LRX
Ciba Vision Corporation
Ophthalmic · 430d
Cleared Sep 09, 2005
VCS S3Y
K051130 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 129d
Cleared Sep 09, 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269 · FLL
Radiant Innovation, Inc.
General Hospital · 115d
Cleared Sep 09, 2005
SATELLITE SPINAL SYSTEM
K051320 · NVR
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Sep 09, 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL...
K051614 · DZE
Lifecore Biomedical, Inc.
Dental · 84d
Cleared Sep 09, 2005
SYNTHES VECTRA-T SYSTEM
K051665 · KWQ
Synthes Spine
Orthopedic · 79d
Cleared Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT,...
K051810 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 66d