BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    RELIEVA STRATUS MICROFLOW SPACER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

    GIZMO

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ACCENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·April 29, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·May 10, 2011

    PENCAN PENCIL POINT SPINAL NEEDLE

    FDA Adverse Event
    Other ·B. BRAUN MEDICAL, INC.·Product code MIA·July 16, 2008

    BD SAF-T-INTIMA PRN YEL 24GA X 0.75IN

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·May 6, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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