BEUDAMED
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    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

    FDA Recall
    Open, Classified ·Boston Scientific Neuromodulation Corporation·Product code LGW·July 17, 2024

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

    FDA Recall
    Open, Classified ·Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China·Product code JIN·November 22, 2025

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Recall
    Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

    CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Recall
    Open, Classified ·St. Jude Medical·Product code MOM·February 7, 2023

    CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Recall
    Open, Classified ·St. Jude Medical·Product code MOM·February 7, 2023

    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Recall
    Open, Classified ·St. Jude Medical·Product code MOM·February 7, 2023

    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.

    FDA Recall
    Open, Classified ·St. Jude Medical·Product code MOM·February 7, 2023

    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NVY·September 30, 2022

    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NVY·September 30, 2022

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·February 4, 2020

    Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NKE·March 19, 2026

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) 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. Component: No

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

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

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

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

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

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

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

    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code NHJ·February 18, 2026

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No

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