BEUDAMED
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    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.

    FDA Recall
    Terminated ·Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel·Product code MSQ·June 7, 2011

    Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.

    FDA Recall
    Terminated ·Trek Diagnostic Systems·Product code JTZ·June 4, 2009

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code JAK·November 5, 2008

    ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064

    FDA Recall
    Terminated ·Abbott Health Products, Inc.·Product code LFH·November 17, 2003

    Alere iScreen Dx Urine Drug Screen Card

    FDA Recall
    Terminated ·Ameditech Inc·Product code LFH·December 15, 2017

    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JFH·March 5, 2018

    FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DFH·May 20, 2021

    Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DFH·November 18, 2020

    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

    FDA Recall
    Terminated ·Ameditech Inc·Product code LFH·June 26, 2017

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEQ·September 11, 2015

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 8, 2016

    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 17, 2021

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FBN·March 31, 2022

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEO·April 23, 2020

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GCP·April 19, 2017