205 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPHYGMOCOR XCEL
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ HT+ 98x30 OM3
FDA UDI
ARGEN CORPORATION, THE·D818122129·Dental porcelain/ceramic restoration kit
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
COBAS 6000 C501MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 6, 2008
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL LTD.·Product code KWA·June 3, 2011
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 27, 2023
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code NFA·June 16, 2015
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·June 16, 2015
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 28, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 14, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 27, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 20, 2026
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022