11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BENELLI ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
DONJOY
FDA UDI
DJO, LLC·00888912005654·COLD PAD, SHOULDER, LOOP, NS
CM TITAMAX IMPLANT 3.5X11
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES CURVED RECONSTRUCTION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BONE PLATE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 14, 2013
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·September 23, 2014
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 12, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025