BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    D-STORM 810NM, D-STORM 980NM

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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

    MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALL TERRAIN WHEELCHAIR (ATW)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 3, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 10, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021