19 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FSH RADIOIMMUNOASSAY TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ultraverse® 018
FDA UDI
Bard Peripheral Vascular, Inc.·00801741156199·Ultraverse® 018 PTA Balloon Dilatation Catheter...
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788200480·5.50mm Rod Holding Forcep
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117536·
KETAC-CEM IN REF. TO K802048
FDA 510(k)
FDA Class 2
·Dental
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020
NA
FDA UDI
Zimmer, Inc.·00889024100015·
NA
FDA UDI
Zimmer, Inc.·00889024099999·
NA
FDA UDI
Zimmer, Inc.·00889024100008·
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO GEO STRUCTURE
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Zimmer, Inc.·00889024071483·
NA
FDA UDI
Zimmer, Inc.·00889024071513·
NA
FDA UDI
Zimmer, Inc.·00889024071506·
NA
FDA UDI
Zimmer, Inc.·00889024071490·
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 20, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 5, 2012
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·August 20, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012