7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Xcess Guiding Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
HUMIDAIRE 2I
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXTRUS 4136
FDA Adverse Event
Death
·BIOTRONIK SE & CO, KG·Product code NVZ·February 19, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 7, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024