9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REXLENE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRESENIUS DIALYSIS DELIVERY SYSTEM
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 7, 2013
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANDOX OPIATES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·February 25, 2020
NX3
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 17, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 24, 2011
CAPTURE-R READY SCREEN
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·September 25, 2008