183 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036151300·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033470954·
CRANIAL MOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
LACTOSORB SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·March 20, 2013
SHORT PORT BTT SURGICAL PORT AND SYRINGE
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·March 8, 2011
RADIFOCUS INTRODUCER II KIT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORP.·Product code DYB·March 14, 2008
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
BD PHOENIX¿ PMIC/ID-107
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025