15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IRRIGATION TRAY
FDA 510(k)
FDA Class 1
·General Hospital
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 14, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 21, 2012
MG II POROUS TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROTATING HEMOSTATIC VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 4, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 14, 2012
SOLETRA
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code MHY·March 16, 2012
SOLETRA
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code MHY·March 16, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 13, 2014
APC PLUS ADHESIVE
FDA Adverse Event
Injury
·3M UNITEK·Product code DYW·June 7, 2007
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·May 20, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 11, 2010
SROM STM ST,36+6L NK,11X16X150
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LPH·January 4, 2013
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017