7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERITEC GREEN CARD PACK BOWIE-DICK TEST
FDA 510(k)
FDA Class 2
·General Hospital
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
FDA 510(k)
FDA Class 2
·Radiology
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 6, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011
NOVASURE
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code MNB·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025