BEUDAMED
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    FLUID DISPENSING SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SureStep™ Foley Tray System Bard® Lubricath Foley

    FDA UDI
    C. R. Bard, Inc.·00801741073946·SureStep® Foley Tray System Bard® Lubricath® Fo...

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517136053·Helix R Plate, 62mm 3-Level

    Bard® Foley Tray with Bard® Hydrophilic-Coated Foley Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741024740·Bard® Foley Tray with Bard® Hydrophilic-Coated ...

    MGB Alert Internal Control Set IC2-480 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951411·The MGB Alert Internal Control Set IC2 consists...

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace

    ACUMED

    FDA UDI
    Acumed LLC·10806378041549·2.3mm Bone Tap

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197491419·Titanium Blade 25x152...

    MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAMBRIDGE HEART OEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIODESIGN POSTERIOR PELVIC FLOOR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAJ·April 3, 2014

    2.4MM VA LOCKING SCREW STARDRIVE 26MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 28, 2007

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·January 21, 2022

    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·March 4, 2024

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QLT·May 13, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·June 3, 2024

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code JJH·June 5, 2019