10 results
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33ms
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Sources: EU EUDAMED, US FDA
CENTURY LIFT TRANSFER SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
ARMADA 35/35LL PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PF 5050 PRESSURE UNIT, MODEL PF 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
RAPIDPOINT 500
FDA Adverse Event
Death
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KQO·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 30, 2007
CONSULTA CRT-P
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 6, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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