BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEALITE II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BERCHTOLD ELEKTROTOM 106 HITT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 22, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 14, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 3, 2014

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015