39 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L14049620K0·Abutment Driver
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
FDA 510(k)
FDA Class 2
·Cardiovascular
INVADER MTHFR 1298
FDA 510(k)
FDA Class 2
·Hematology
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 25, 2021
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
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
INGEVITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 3, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 31, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
PRODIGY SM STAT SHT RT 12.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 7, 2013
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 7, 2013
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 7, 2025