7 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITA LUMEX AC
FDA 510(k)
FDA Class 2
·Dental
3B FLEX-LITE
FDA 510(k)
FDA Class 2
·Anesthesiology
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CLICKX LOCKCAP T25 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 27, 2013
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·July 13, 2011
INVACARE LIFTS AND SLINGS
FDA Adverse Event
Injury
·INVACARE CORP.·Product code FNG·September 30, 2008
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025