7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOP HYPODERMIC SYRINGE PISTON
FDA 510(k)
FDA Class 2
·General Hospital
Hill-Rom Wireless Connectivity Module
FDA 510(k)
FDA Class 2
·Physical Medicine
HL 188 & HL 189 BODY FAT METER
FDA 510(k)
FDA Class 2
·Cardiovascular
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 15, 2015
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