7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUDWIG Electrosurgical Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 24, 2011
GAS SUPPLY LINE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·November 3, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025