8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
FDA 510(k)
FDA Unclassified
·Unknown
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014
ENDEAVOR SPRINT RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·November 22, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MED SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 22, 2010
CER BIOLOXD OPTION HD 32MM, model # 650-1056
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 10, 2018
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