12 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBI XFIX DFS OPTIROM ELBOW FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
Armada
FDA UDI
Nuvasive, Inc.·00887517235282·Armada Ti 3CO Retractor, 15mm Spoon
RESPIRATOR DISCONNECT ALARM
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 27, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 27, 2024
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 4, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·February 15, 2011
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024