8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
FDA 510(k)
FDA Class 2
·Immunology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517392558·CoRoent® XL, 14x18x50mm
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
FDA 510(k)
FDA Class 1
·Dental
PSF-50ET
FDA 510(k)
FDA Class 2
·Radiology
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 4, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 4, 2014
KEEPSAFE DELUXE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·December 7, 2012
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020