7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
FDA 510(k)
FDA Class 2
·Orthopedic
AMSURE URETHRAL CATHETERIZATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SG Lanset I, SG Lancets, Soft Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 28, 2013
SUPERA BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·IDEV TECHNOLOGIES, INC.·Product code FGE·December 14, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 12, 2014
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
FDA Enforcement
Class II
·Terminated·Barco Inc.·November 11, 2015