7 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MF SC Facial Toning System
FDA 510(k)
FDA Class 2
·Neurology
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
FDA 510(k)
FDA Class 2
·Immunology
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 6, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 18, 2013
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