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

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    KM-5 METAL BACKED ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111944·3M™ Victory Series™ First Molar Bands, 902-279,...

    ML EYE SPEAR, MODEL ML 27 ES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INCU I

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POLYFORM¿ SYNTHETIC MESH

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTO·June 30, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 8, 2013

    BIOGLUE SURGICAL ADHESIVE

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code MUQ·November 18, 2010

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012