7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAMAN POTTS COURNAND NEEDLE
FDA 510(k)
FDA Class 1
·Cardiovascular
NOVATECH TALCAIR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
InZone IST Detachment System; IZDS Connecting Cable
FDA 510(k)
FDA Class 2
·Neurology
MICRO INCISION VACUUM PHACO PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·April 11, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·November 29, 2012
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