7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MIC (SPECIFIC LINE) REPLACEMENT KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRATEMP FIRM, FAST AND REGULAR SET
FDA 510(k)
FDA Class 2
·Dental
Arthrex SwiveLock Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·TENEX HEALTH·Product code LFL·April 9, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
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