BEUDAMED
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    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024

    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PEP·February 15, 2022

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LON·June 26, 2025

    biokitHSV-2 Rapid Test, REF: 300028001

    FDA Recall
    Open, Classified ·Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain·Product code LGC·September 28, 2022

    Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

    FDA Recall
    Open, Classified ·GN Otometrics Horskatten 9 Taastrup Denmark·Product code DSA·August 1, 2019

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    FDA Recall
    Open, Classified ·Western/Scott Fetzer Company·Product code CAN·January 3, 2023

    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

    FDA Recall
    Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021

    Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.

    FDA Recall
    Open, Classified ·Dynasthetics LLC·Product code CBN·May 9, 2022

    Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603

    FDA Recall
    Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021

    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

    FDA Recall
    Open, Classified ·Western/Scott Fetzer Company·Product code CAN·October 16, 2021

    Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.

    FDA Recall
    Open, Classified ·Getinge Group Logistics America, LLC·Product code CBK·September 17, 2020

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FQH·May 25, 2022