8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
MEDRO SPD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACL TIGHTROPE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 24, 2013
AUTOPULSE® LIFEBAND
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·September 30, 2014
KAPPA 900 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019