7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVARRE UNIVERSAL DRAINAGE CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ZOLL M SERIES 12SL ANALYSIS OPTION
FDA 510(k)
FDA Class 3
·Cardiovascular
EndoChoice Select Injection Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code DXY·February 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code ILS·July 22, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024