8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
FDA 510(k)
FDA Class 2
·Neurology
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111147·FOX EYE SHIELD W/ GARTER PED PACK OF 50
Active-X Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
AGGREGOMETER, DUAL CHANNEL PLATELET
FDA 510(k)
FDA Class 2
·Hematology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 13, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 23, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025