BEUDAMED
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    MONOPOLY PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609607·BERCHTOLD 5.25" SOFTCARE PLUS

    PROXIMAL LATERAL TIBIA PLATE, LEFT, 8 HOLE

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665039351·

    ESOP HA FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·December 29, 2021

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Injury ·EUROSETS S.R.L.·Product code DTZ·October 13, 2021

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 20, 2022

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013

    HEARTSTREAM FR2

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 14, 2011

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·November 22, 2021

    BD TEXIUM¿ NEEDLE-FREE SYRINGE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022

    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

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    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