8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Perifit Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
MACROPORE CARDIO-WRAP (TS)
FDA 510(k)
FDA Class 2
·Cardiovascular
PAGODA PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022