10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACON ON CALL DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131469·TiBase NB NP .3G E
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
FDA 510(k)
FDA Class 2
·Radiology
STAXXSD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS HIGH DEFINITION LCD MONITOR
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code NWB·May 8, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
MOZEC¿ RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022
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