9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORiGO System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
SENSUS
FDA 510(k)
FDA Class 2
·Neurology
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 5, 2023
GLUCOSE SENSOR FREESTYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code MDS·January 19, 2022
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
JAGWIRE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·November 3, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 11, 2013