8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sentimag System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOBICATH TRANSSEPTAL NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Implacil Implant System
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·November 6, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code IKZ·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025