30 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARROW PRESSURE INJECTABLE PICC
FDA 510(k)
FDA Class 2
·General Hospital
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
BD EMERALD SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL, MEDICATION DELIVERY SOLUTIONS·Product code FOZ·April 29, 2024
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WARMER 2000LD
FDA 510(k)
FDA Class 1
·Physical Medicine
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 13, 2022
2-L HUB CONNECT ASSY REPLACEMENT SET
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code NFK·April 10, 2013
ACRYSOF TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 13, 2008
PROGENIX DBM PUTTY
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQV·April 18, 2011
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 11, 2023
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 5, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 8, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 6, 2022
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 8, 2023
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 6, 2023
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 5, 2023
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 14, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022