8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LX-100 SLIDE STAINER
FDA 510(k)
FDA Class 1
·Pathology
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376242095·Tap, Cervical, 4.5mm
GENADYNE A4 POWERED SUCTION PUMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUBBER DAM
FDA 510(k)
FDA Class 1
·Dental
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025