8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERADIUM V NON-PRECIOUS CERAMIC ALLOY
FDA 510(k)
FDA Class 2
·Dental
artegral life
FDA UDI
Merz Dental GmbH·D7091993572·anteriors; shade BL2; mould BIM
EXTERNAL DISTRACTION SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036057404·
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
R650 QDASM COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·March 7, 2013
SPACEMAKER PREPERITONEAL DIST BALLOON
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GEX·January 21, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014