7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO ENVOY AND VISTA BRITE TIP
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 3, 2014
LINEAR 7.5 FR 40 CC IAB
FDA Adverse Event
Injury
·DATASCOPE CORP·Product code DSP·August 19, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 3, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025