9 results
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19ms
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Sources: EU EUDAMED, US FDA
IMPACT MODEL 601
FDA 510(k)
FDA Class 2
·Anesthesiology
START IT WITH & WITHOUT I.V. CATH. UNIT
FDA 510(k)
FDA Class 2
·General Hospital
IN:C2 SPINAL FIXATION SYSTME
FDA 510(k)
FDA Class 2
·Orthopedic
MEDIVATORS DSD EDGE
FDA Adverse Event
MEDIVATORS·Product code FEB·May 30, 2014
SROM NRH TIB PLAT ASSY XS 12MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code KRO·November 21, 2012
KOTEX SECURITY TAMPONS
FDA Adverse Event
Malfunction
·QINGDAO P&B CO., LTD.·Product code HEB·September 17, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024