7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROCLIP, WILLIAMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS XCHF TYPE B180Y1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Varian Head Frame
FDA 510(k)
FDA Class 2
·Radiology
EASYTRAK
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 10, 2012
ACCU-CHEK ACTIVE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·September 26, 2007
AEQUALIS REVERSED HEXAGONAL DRIVER TIP
FDA Adverse Event
Malfunction
·TORNIER SAS·Product code KWS·May 15, 2015
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024