10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
FDA 510(k)
FDA Class 2
·Dental
CAPSTONE PTC™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169187474·SPACER 3992216 22MM X 16MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198543·AK3 Ultra Insert Trial Size 2, 16mm
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
FDA 510(k)
FDA Class 2
·Physical Medicine
ARCOLITH 2100-CARDIAC PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
ASAHI APS 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
EVERA XT VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·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