7 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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9Line
FDA 510(k)
FDA Class 2
·Cardiovascular
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
FDA 510(k)
FDA Unclassified
·Unknown
CHOYANG THERMAL MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014
BV LIBRA 9" SURVEY
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZL·August 10, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025