7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE CIRCULATOR BOOT
FDA 510(k)
FDA Class 2
·Cardiovascular
Mytens Model: BW-TSX
FDA 510(k)
FDA Class 2
·Neurology
BD GENEOHM STAPHSR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·January 6, 2011
1.5T SIGNA HDX
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·July 8, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026