BEUDAMED
    4 results · 75ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HENORA 300PSI I.V. CATHETER EXTENSION SET

    FDA Adverse Event
    Malfunction ·RGI MEDICAL MANUFACTURING INC.·Product code GCD·March 14, 2014

    HENORA 300PSI I.V. CATHETER EXTENSION SET

    FDA Adverse Event
    Malfunction ·RGI MEDICAL MANUFACTURING INC.·Product code GCD·March 20, 2014

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Recall
    Terminated ·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Enforcement
    Class II ·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014