BEUDAMED
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    EVair air compressor, model numbers: M1230849 and M1230847

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010

    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

    FDA Recall
    Terminated ·Shape Medical Systems, Inc·Product code BTY·December 23, 2014

    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BTI·December 5, 2013

    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.

    FDA Recall
    Terminated ·Shape Medical Systems, Inc·Product code BTY·May 28, 2014

    Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.

    FDA Recall
    Open, Classified ·Medtronic CoreValve LLC·Product code DTI·January 14, 2020

    Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010

    Sizer, Heart-Valve, Prosthesis

    FDA classification
    FDA Class 1 ·Sizer, Heart-Valve, Prosthesis

    Compressor, Air, Portable

    FDA classification
    FDA Class 2 ·Compressor, Air, Portable

    Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

    FDA classification
    FDA Class 2 ·Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

    Calculator, Predicted Values, Pulmonary Function

    FDA classification
    FDA Class 2 ·Calculator, Predicted Values, Pulmonary Function

    Hemostatic Metal Clip For The Gi Tract

    FDA classification
    FDA Class 2 ·Hemostatic Metal Clip For The Gi Tract

    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

    FDA Recall
    Terminated ·Normand Informatique Normand Informatique Sci Git; 57 Grand place; Cs 10451 Arras CEDEX France·Product code JQP·October 16, 2017