7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERLOCKING INTRAMEDULLARY NAILS
FDA 510(k)
FDA Class 2
·Orthopedic
PERRY SUTURING SET W/ANESTHETIC
FDA 510(k)LASER LENS-VARIOUS MODELS
FDA 510(k)
FDA Class 2
·Ophthalmic
ENDURANT II
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 19, 2014
RELIANT STENT GRAFT BALLOON CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code DQY·October 19, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 24, 2012
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025