12 results
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41ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EpiAccess Control Unit
FDA UDI
EPIEP, INC.·B300A00050·
EpiAccess Needle
FDA UDI
EPIEP, INC.·B3000399139500·
EpiAccess Control Unit
FDA UDI
EPIEP, INC.·B300A00020·
EPIACCESS SYSTEM
FDA Adverse Event
Death
·EPIEP, INC.·Product code DYB·March 17, 2017
EPIEN MEDICAL, INC.
FDA registration
EPIEN MEDICAL, INC.·2 products·🇺🇸 United States
HYBENX Advanced Dental Debridement
FDA UDI
Epien Medical, Inc.·00860004740315·HYBENX Advanced Dental Debridement is topical l...
HYBENX Root Canal Cleanser
FDA UDI
Epien Medical, Inc.·00860004740308·EPIEN Root Canal Cleanser is indicated for use ...
HYBENX Advanced Dental Debridement Gel
FDA UDI
Epien Medical, Inc.·00860004740322·HYBENX Advanced Dental Debridement is a topical...
ORALMEDIC
FDA Adverse Event
Injury
·EPIEN MEDICAL, INC.·Product code NEC·May 22, 2025
HYBENX GEL
FDA Adverse Event
Injury
·EPIEN MEDICAL, INC.·Product code KJJ·November 22, 2023
PLUM 360 DRIVER NEW
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·February 13, 2023
PLUM 360¿ INFUSER
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·January 31, 2023