BEUDAMED
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    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No

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

    Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

    FDA Recall
    Open, Classified ·Ambu Inc.·Product code CBI·September 16, 2024

    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000

    FDA Recall
    Open, Classified ·Ambu Inc.·Product code CBI·June 3, 2022

    AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    FDA Recall
    Open, Classified ·Hamilton Co·Product code JQW·January 15, 2021

    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

    FDA Recall
    Open, Classified ·WAVi Co.·Product code GWQ·December 8, 2023

    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTY·November 21, 2022

    BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632and 231633

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro susceptibility testing.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code LON·February 29, 2024

    BD COR System Software. Model Number: 444829.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MAQ·June 23, 2025

    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code KZJ·April 7, 2026