7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TOF-Cuff monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
FDA 510(k)
FDA Class 2
·Physical Medicine
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
FDA 510(k)
FDA Class 2
·Microbiology
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
HUDSON THERMAGARD NEBULIZER HEATER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZE·June 17, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 17, 2014