7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prestige Coil System (Prestige Packing Line Extension)
FDA 510(k)
FDA Class 2
·Cardiovascular
THE INCOURAGE SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NeuViz 128 Multi-slice CT Scanner System
FDA 510(k)
FDA Class 2
·Radiology
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·October 20, 2008
LOCKING SCREW AXSOS 4.0MM / L38MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·August 10, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025