8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHEELCHAIR CUSHIONS
FDA 510(k)
FDA Class 1
·Physical Medicine
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106516·
SERVO-U Ventilator System, SERVO-n Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENDRIL DX
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·June 5, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·November 29, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
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