9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH
FDA 510(k)
FDA Class 2
·General Hospital
CHURCHILL-H VENTED IV SET
FDA 510(k)
FDA Class 2
·General Hospital
KEATES IRRIGATION/ASPIRATION/VITREOUS
FDA 510(k)
FDA Class 2
·Ophthalmic
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014
ENDOTAK SQ
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·November 9, 2010
MICRO VENTRICULAR BOLT ICP / TEMPERATURE MONITOR
FDA Adverse Event
Malfunction
·INTEGRA NEURO SCIENCES CA/USA·Product code GWM·December 27, 2012
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020