9 results
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29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Balloon Inflation System
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111012501·SKLARLITE JEWELERS FCP #3 STR
MICROGENICS CYCLOSPORINE CONTROL KIT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FLAATZ 600 SERIES (FLAATZ 600/601)
FDA 510(k)
FDA Class 2
·Radiology
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 12, 2026
BD LUER-LOK
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 2, 2026
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 6, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·September 2, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2013