10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClearCheck Model RADCC V2
FDA 510(k)
FDA Class 2
·Radiology
ELMED
FDA UDI
ELMED INCORPORATED·00842180108592·5 MM DIA., 33 CM, INSULATED SPATULA ELECTRODE,...
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
FDA 510(k)
FDA Class 2
·Microbiology
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 30, 2024
GORE-TEX
FDA Adverse Event
Death
·*·Product code FIQ·November 4, 2008
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021