7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TUBING, AXIOM SILICONE PENROSE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AVANTE Z ZIRCONIA (AS)3 BLOCKS
FDA 510(k)
FDA Class 2
·Dental
SuperCable® Iso-Elastic Cerclage System
FDA 510(k)
FDA Class 2
·Orthopedic
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
STRYKER IMPACTION BUR GUARD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS·Product code GET·July 26, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025