8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHARPS-TAINER
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994870001·TRAY 2942054 DL SPPRT SET UPPER TRAY 1
IMACOR ZURA EVO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SILIMED PECTORAL IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ACCLAIM ENCORE 2.25
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 9, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 4, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2014
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