BEUDAMED
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    Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.

    FDA Recall
    Terminated ·Xstrahl Limited·Product code JAD·April 26, 2021

    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012

    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

    VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JID·June 12, 2013

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JBD·June 29, 2004

    Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code JAD·June 26, 2009

    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

    FDA Recall
    Terminated ·Xstrahl Limited·Product code JAD·August 27, 2021

    INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012

    INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code JAD·July 1, 2011

    HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

    FDA Recall
    Terminated ·Sebia, Inc.·Product code JBD·August 29, 2006

    Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code JAD·June 26, 2009

    INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code JAD·October 25, 2012

    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany·Product code JAD·August 30, 2017

    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.

    FDA Recall
    Terminated ·Laerdal Medical (Suzhou) Co., Ltd. Science & Technology Ind. Park No.·Product code JCX·December 18, 2020

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Recall
    Terminated ·MEDLINE IND·Product code KMJ·December 12, 2016

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Enforcement
    Class II ·Terminated·MEDLINE IND·January 18, 2017

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Recall
    Terminated ·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017

    Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution * Sterile * Manufactured by: Bausch & Lomb, Rochester, NY 14609.

    FDA Recall
    Terminated ·Bausch & Lomb·Product code LPN·April 13, 2006

    BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·May 17, 2007

    BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PIC·January 14, 2019