11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLUOROPLASTIC VENTILATION TUBES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ZMR®
FDA UDI
Zimmer, Inc.·00889024157194·
ZMR®
FDA UDI
Zimmer, Inc.·00889024157217·
ZMR®
FDA UDI
Zimmer, Inc.·00889024157200·
THERMAPULSE
FDA 510(k)
FDA Class 2
·Physical Medicine
EZ-Inject Single use Needle
FDA 510(k)
FDA Class 2
·General Hospital
HALO PKS
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code HIN·February 28, 2013
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 15, 2011
ATTAIN STARFIX
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
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