BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    CONSERVE PRESSFIT FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EZ-COMFORT TRANSPORTER 2000 SERIES

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-RT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·April 29, 2013

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 28, 2011

    INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYB·July 21, 2008

    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