7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Yumizen H2500
FDA 510(k)
FDA Class 2
·Hematology
SOFTECH PLUS ETC02 CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
Oneday Mini Implant System
FDA 510(k)
FDA Class 2
·Dental
ENDOVIVE? SECURI-T?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 6, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 22, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025