7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUINTON SINGLE LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AFM ULTRA AG DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
MiiS Horus Eye Anterior Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 25, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 2, 2013
PLUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSD·November 8, 2010
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