BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    SURGI-SPRAY O.R. IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MTA-FILLAPEX

    FDA 510(k)
    FDA Class 2 ·Dental

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

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

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 3, 2010

    SWEET TIP

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code DTB·July 3, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012

    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