7 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUIDEL CHLAMYDIA POSITIVE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
YASARGIL ANEURYSM CLIPS, MODIFICATION
FDA 510(k)
FDA Class 2
·Neurology
PUMP IN STYLE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·December 22, 2010
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·February 15, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 29, 2014
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021