7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BINDAZYME ANTI-DSDNA EIA KIT
FDA 510(k)
FDA Class 2
·Immunology
SYNERMED URIC ACID REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
FDA 510(k)
FDA Class 1
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
UNKNOWN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·January 13, 2011
INSYNC III
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWP·August 8, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021