7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTICS HIGH SPEED HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
SPONGE, CURITY WASHED GAUZE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROGENIX DBM PUTTY AND PASTE
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 21, 2014
RESTORE PRIME
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·September 26, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2015
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025