7 results
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25ms
·
Sources: EU EUDAMED, US FDA
DRI-CLAVE LIQUID KLEENZALL
FDA 510(k)
FDA Class 1
·Dental
NEONATAL MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 18, 2014
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 25, 2010
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