9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADROIT Guiding Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EVERDIXIE
FDA UDI
CAREMATE MEDICAL DEVICE CO., LTD·06971329980066·
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249288·PrimePadPlus-K14-3422
AXIOM FASCIAL CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: VIEWSTATION
FDA 510(k)
FDA Class 2
·Radiology
IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 3, 2013
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 27, 2014
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 29, 2011
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017