BEUDAMED
    41 results · 17ms · Sources: EU EUDAMED, US FDA

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    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·October 30, 2024

    GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

    FDA Enforcement
    Class II ·Terminated·LW Scientific, Inc.·April 3, 2019

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 26, 2018

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    FDA Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·December 6, 2023

    BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025