8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIPOLAR COAGULATING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARx SAI
FDA UDI
Life Spine, Inc.·00190837195793·
GPS Angled Abutment
FDA 510(k)
FDA Class 2
·Dental
ACUBAND ACUPRESSURE WRIST BAND DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
LEICA M525 F50
FDA Adverse Event
Malfunction
·LEICA MICROSYSTEMS SCHWEIZ AG, MAX SCHMIDHEINY·Product code EPT·June 12, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MPRI·Product code NIK·February 9, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·January 5, 2011
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