BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    TIGER CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAPORT™

    FDA UDI
    LSI Solutions, Inc.·00850012846345·RAPORT™ KIT

    Berman Airways (color coded)

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043815106·110MM

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115100·Handle, Targeting Needle

    OS-2000 OPTICAL SONOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MULTI HI-FLO PNEU, WISAP #7080

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 29, 2013

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 19, 2011

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 25, 2008

    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