BEUDAMED
    23 results · 17ms · 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: Ongoing ×

    EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

    FDA Enforcement
    Class I ·Ongoing·Red Medical Supplies·October 20, 2021

    EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

    FDA Enforcement
    Class I ·Ongoing·Red Medical Supplies·October 20, 2021

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    FDA Enforcement
    Class I ·Ongoing·Red Medical Supplies·October 20, 2021

    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    Mito Red Light, Super Mobile

    FDA Enforcement
    Class II ·Ongoing·MITO RED LIGHT INC·June 24, 2026

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·March 8, 2023

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·September 28, 2022

    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·February 14, 2024

    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

    FDA Enforcement
    Class II ·Ongoing·GETINGE US SALES LLC·December 18, 2019

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·September 28, 2022

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·September 28, 2022

    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·February 21, 2024

    BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023

    BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

    FDA Enforcement
    Class II ·Ongoing·Maquet Medical Systems USA·June 7, 2023