21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceracell Ortho Foam
FDA 510(k)
FDA Class 2
·Orthopedic
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
TRICOS A RESORBABLE SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
FLEXTOME¿ CUTTING BALLOON¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·July 27, 2011
2520274-2013-03591
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 21, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 17, 2008
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 2, 2019
BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 5, 2019
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
CONNECTOR C35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·April 30, 2021
BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 14, 2021
BD INJECTOR N35-O¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·May 28, 2019
INFUSION ADAPTER C100-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·March 2, 2020
BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 15, 2019
BD PHASEAL¿ OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 20, 2019
BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 2, 2019
BD PHASEAL OPTIMA CONNECTOR (C35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 12, 2019
BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 14, 2019
BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 9, 2019
BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 14, 2019