BEUDAMED
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    Able Medical Devices Valkyrie Thoracic Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

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    FDA UDI
    ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042124486·CLEAR DOUBLE ENDED OCCLUSAL RETRACTOR - LONG

    PNS MAGNETIC STIMULATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    FDA Adverse Event
    Malfunction ·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·October 16, 2008

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·August 11, 2011

    TAXUS® LIBERTÉ® ATOM?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021