9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EmboGuide
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
FDA 510(k)
FDA Class 2
·Cardiovascular
MERIT BIPOLAR COAGULATION PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 5, 2014
ACUSON
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS USA INC.·Product code IYN·May 23, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 28, 2011
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026