9 results
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21ms
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Sources: EU EUDAMED, US FDA
MOLINEA UNDERPADS
FDA 510(k)
FDA Class 1
·General Hospital
Halyard
FDA UDI
Avanos Medical, Inc.·10680651984347·HALYARD* Introducer Kit for Gastrostomy Feedin...
THERMAGE THERMACOOL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Extremity Medical Calcaneal Osteotomy Device
FDA 510(k)
FDA Class 2
·Orthopedic
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2014
TRSX5RC/WD66/28/R/U240 9153641587
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 15, 2015
CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·October 16, 2017
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