BEUDAMED
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    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

    FDA Recall
    Open, Classified ·Defibtech, LLC·Product code MKJ·March 18, 2025

    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQK·September 5, 2024

    Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·September 12, 2025

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

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

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

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

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

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

    FDA Recall
    Open, Classified ·GETINGE US SALES LLC·Product code DTZ·November 13, 2019

    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

    FDA Recall
    Open, Classified ·Cypress Medical Products LLC·Product code GTZ·August 20, 2024

    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 Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·December 12, 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 Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    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 Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

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

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    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 Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·January 16, 2024

    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 Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023