8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
CEROX
FDA 510(k)
FDA Class 2
·Cardiovascular
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 12, 2008
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 1, 2011
PLV-102
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 15, 2013
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