BEUDAMED
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    E-BEAM SERVICES, INC.

    FDA registration
    E-BEAM SERVICES, INC.·19 products·🇺🇸 United States

    E-BEAM SERVICES, INC.

    FDA registration
    E-BEAM SERVICES, INC.·6 products·🇺🇸 United States

    NUVAGEN

    FDA Adverse Event
    Malfunction ·RUSPAK CORPORATION·Product code KOZ·November 17, 2017

    MC-500

    FDA Adverse Event
    Malfunction ·NIDEK INCORPORATED·Product code HQF·January 9, 2017

    COULTER® LH 750 SLIDEMAKER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·March 6, 2012

    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

    FDA Recall
    Terminated ·SonoSite, Inc.·Product code IYO·September 11, 2013

    Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Recall
    Terminated ·Hand Biomechanics Lab Inc·Product code JEC·September 14, 2016

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO. LTD.·Product code LXS·May 16, 2019

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO. LTD.·Product code LXS·May 16, 2019

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD·Product code LXS·November 21, 2017

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO.,LTD·Product code LXS·August 31, 2017

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO. LTD.·Product code LXS·November 20, 2019

    Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code IZO·June 14, 2010

    Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room. Intended use: The Trilogy Mx" System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. 7/9/2013 - UPDATE: Determined that the correction only applied to C3 users, not C1 and C2 users.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·December 1, 2009

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO.,LTD·Product code LXS·October 5, 2017

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD·Product code LXS·April 27, 2018

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code LZS·November 18, 2014

    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

    FDA Recall
    Terminated ·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023

    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·August 17, 2012

    MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code NZT·November 19, 2019