BEUDAMED
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    PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605012·BERCHTOLD OPERON D850, D750 2" SOFTCARE

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707000990·MICRO SECT SCREWS U S/STEEL 4mm EXPANS.

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179857·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450443033·

    CORTEK CYSTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 26, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 22, 2008

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2011

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    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