8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANAN FRANSEENE NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bio-Medicus Life Support Catheter and Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
4FR S/L GROSHONG PICC W/SAFETY IV CATH
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code LJS·April 11, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 29, 2012
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
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