BEUDAMED
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    Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 5, 2008

    MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KMC·October 11, 2013

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code GDR·May 11, 2017

    ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75

    FDA Recall
    Terminated ·Edwards Lifesciences Technology SARL·Product code DYG·November 27, 2006

    Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code KAC·December 15, 2006

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSHIELD (an Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 744HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DYG·February 9, 2009

    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DYG·February 9, 2009

    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019

    Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005