7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GALEN
FDA 510(k)
FDA Class 2
·Radiology
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
FDA 510(k)
FDA Class 2
·Orthopedic
AMIGO J-9
FDA 510(k)
FDA Class 2
·Physical Medicine
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 19, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 14, 2010
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026