7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GASTRIC SUMP TUBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ENDOSEAL
FDA 510(k)
FDA Class 2
·Dental
2008T HEMODIALYSIS SYS., WITH CDX
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 25, 2014
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO KG·Product code NVZ·November 5, 2012
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Death
·SPECTRANETICS CORPORATION·Product code MFA·September 7, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018