8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOCHRON(R) KACT
FDA 510(k)
FDA Class 2
·Hematology
CER-S
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
FDA 510(k)
FDA Class 2
·Neurology
UNO
FDA Adverse Event
Injury
·LIKO AB·Product code FSA·June 9, 2014
PRIME 5TH WHEEL STRETCHER, 30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 14, 2013
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code MNI·November 29, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025