8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OEC 3D
FDA 510(k)
FDA Class 2
·Radiology
Philips
FDA UDI
Sbo Hearing A/S·05714464042999·CHARGER, MNB T R DEMO
MEDINAUT KYPHOPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2013
TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·November 18, 2015
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025