12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REBUILDER(TM)
FDA 510(k)
FDA Class 2
·Neurology
GC Initial™
FDA UDI
Gc America Inc.·15400556704162·GC Initial™ AL Shoulder Opaq. SO-39, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228740851·GC Initial™ Ti Enamel Occlusal EO-15, 20g
OMNI PLANE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DRAGER PEEP SYSTEM D
FDA 510(k)
FDA Class 2
·Anesthesiology
STARDRIVE(TM) SCREWDRIVER T15
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 11, 2019
2.4MM STARDRIVE SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·June 16, 2014
NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·December 14, 2012
EASYTRAK 3
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 19, 2010
OSTYCUT BONE BIOPSY NEEDLE
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code DWO·September 7, 2015
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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