9 results
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19ms
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Sources: EU EUDAMED, US FDA
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SRO 32100 ROT 351
FDA UDI
Philips Medical Systems DMC GmbH·00884838075962·diagnostic x-ray tube housing assembly
AUSTIN ENDOLYMPH DISPERSMENT SHUNT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PRUITT IRRIGATION AND OCCLUSION CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FMP HIP
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWA·June 16, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 19, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 14, 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