8 results
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18ms
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Sources: EU EUDAMED, US FDA
EXTENSION DEVICE 1416
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IONTOPHORESIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
FDA 510(k)
FDA Unclassified
·Unknown
U0707 TINA SINGLE PUMP NIBPLCD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MIAMI LAKES·Product code KDI·October 18, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 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