13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ICHOR 7F Embolectomy System (ICH-7F)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 1, 2025
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·March 27, 2025
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·February 6, 2025
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·March 27, 2025
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·March 27, 2025
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
FDA 510(k)
FDA Class 2
·Radiology
QStat Cartridge
FDA 510(k)
FDA Class 2
·Hematology
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 19, 2019
BD PEN NEEDLE 32X4 LA 5B
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 6, 2020
TRIATHLON CR PRECISION FEMORAL PREP KIT SIZE 5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 14, 2008
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 16, 2013