9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340348195·SS NON-LOCKING SCREW L14MM D5MM
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347037·SS NON-LOCKING SCREW L14MM D5MM STERILE
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UniWeb 8.0
FDA 510(k)
FDA Class 2
·Radiology
LAG SCREW, TI GAMMA3® Ø10.5X90MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·June 2, 2014
CONTOUR LINK
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·November 21, 2012
FIXODENT EXTRA HOLD
FDA Adverse Event
Injury
·PROCTER & GAMBLE·Product code KOO·September 20, 2010
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