9 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSTONE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169187481·SPACER 3992215 22MM X 15MM
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
FDA 510(k)
FDA Class 2
·Neurology
PENTEX UPPER G.I. SCOPE MODEL FG-28A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASAHI REXEED-S DIALYZERS
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·March 1, 2013
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 15, 2011
MYOCARDIAL LEAD
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·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