8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Atlantic Safety Products, Inc.
FDA registration
Atlantic Safety Products, Inc.·2 products·🇺🇸 United States
T2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Su2ura Approximation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NX3
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·November 7, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
COVIDIEN
FDA Adverse Event
Malfunction
·COVIDIEN SURGICAL DEVICES·Product code GEI·July 5, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024