BEUDAMED
    5 results · 13ms · 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 Status: Ongoing ×

    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024

    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 22, 2024

    Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

    FDA Enforcement
    Class II ·Ongoing·Philips North America·October 16, 2024

    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024