11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
FDA 510(k)
FDA Class 2
·Radiology
Aspira Luer Adapter
FDA UDI
Bard Access Systems, Inc.·00801741045042·Aspira Luer Adapter
Colibri Endoscopy System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
A SLEEP ASSESSMENT DEVICE
FDA 510(k)
FDA Class 2
·Neurology
SYNERGY¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 4, 2015
ISOLINE
FDA Adverse Event
Injury
·SORIN CRM·Product code MRM·March 1, 2013
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
REVEAL LINQ
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·August 8, 2014
HEMOPRO 2 EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·March 18, 2024
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