7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFIED IDEIA CHLAMYDIA TEST
FDA 510(k)
FDA Class 1
·Microbiology
Clarius Ultrasound Scanner
FDA 510(k)
FDA Class 2
·Radiology
ATLAS-BASED AUTOSEGMENTATION
FDA 510(k)
FDA Class 2
·Radiology
STRAIGHT TIP T25 DRIVER-LONG
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·June 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·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