7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Bipolar Forceps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHT-6500, PHT-60CFO
FDA 510(k)
FDA Class 2
·Radiology
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 1, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PAH·July 16, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025