BEUDAMED
    40 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Enforcement
    Class II ·Terminated·Flexicare Medical Ltd.·January 22, 2020

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

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

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

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

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

    FDA Enforcement
    Class III ·Terminated·Datascope Corporation·June 13, 2018

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    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

    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·January 18, 2017

    Esaote brand Formul@ ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand ArchiWin Colour ECG System; part 9704325000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Archimed 4220 ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Formula for Archimed ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code KZH·March 8, 2005

    Lorad M-IV Mammography System

    FDA Recall
    Terminated ·Lorad, A Division of Hologic·Product code IZH·January 14, 2004

    Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Recall
    Terminated ·International Medsurg Connection, Inc.·Product code KZH·June 23, 2017