7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Lifetech Cardio Temporary Pacemaker
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIWAY ENDONASAL ACCESS GUIDE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 14, 2008
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 18, 2011
AGILITY POST AUG TALAR SZ 3
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HSN·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025