9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
WAKO AUTOKIT URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ultramatrix EUS Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROMUS ELEMENT ? LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 18, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·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
LOGIC CR FEMORAL CEM, LEFT, SZ 6
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 6, 2024
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
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