14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CX50N(CX50YQS)
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418157·House Retractor with hinge, 16.5cm,
left s...
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX, LLC·Product code FPA·November 21, 2018
ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)
FDA Adverse Event
Malfunction
·INFUTRONIX LLC·Product code FPA·October 30, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
UNKNOWN PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 22, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 22, 2011
LS CLAVE PORT EXT 7"
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FPA·September 15, 2008
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 21, 2019
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017