7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
FDA 510(k)
FDA Class 2
·Anesthesiology
ADSEAL ROOT CANAL SEALER
FDA 510(k)
FDA Class 2
·Dental
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SCREWDRIVER FOR SYNFIX(TM)-LR
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HXX·November 11, 2014
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011
DEXCOM SEVEN SYSTEM SENSOR
FDA Adverse Event
Injury
·DEXCOM·Product code MDS·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025