8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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METALYZER, MODEL 2; METALYZER, MODEL 3
FDA 510(k)
FDA Class 2
·Anesthesiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993641·anteriors; shade BL4; mould IM
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBAS FARA CENTRIFUGAL ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·March 7, 2013
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 26, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024