BEUDAMED
    238 results · 14ms · Sources: EU EUDAMED, US FDA

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    SQ40S Blood Transfusion Filter

    FDA Recall
    Open, Classified ·GVS TM, Inc·Product code CAK·November 3, 2025

    ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C

    FDA Recall
    Open, Classified ·Zoll Medical Corporation·Product code MKJ·May 31, 2024

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Recall
    Open, Classified ·GS Biomark LLC·Product code QJR·August 8, 2022

    Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·May 17, 2024

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Recall
    Open, Classified ·ZOLL Medical Corporation·Product code MKJ·February 13, 2025

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code NJR·December 13, 2024

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    FDA Recall
    Open, Classified ·Philips North America·Product code DSI·January 18, 2023

    RAPIDPOINT 500 Blood Gas System

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·September 26, 2023

    RAPIDPOINT 500e Blood Gas System

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·September 26, 2023

    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·June 25, 2020

    a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100

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

    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·July 31, 2023

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    FDA Recall
    Open, Classified ·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DTQ·October 18, 2024

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·July 31, 2023

    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·December 19, 2025

    VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·December 19, 2025

    Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

    FDA Recall
    Open, Classified ·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025

    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. National Hi-Tech Dev. Zone NO.·Product code BSZ·October 11, 2017

    Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. National Hi-Tech Dev. Zone NO.·Product code BSZ·October 11, 2017