BEUDAMED
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    ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace

    MOSAIC LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARACHNOPHLEBECTOMY NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·May 8, 2014

    VISIONAIRE LEGION FE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KDC·October 23, 2012

    CONING WORKS LLC

    FDA Adverse Event
    Injury ·CONING WORKS, LLC·Product code KCN·August 9, 2010

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·May 18, 2021

    Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code BYD·April 29, 2011

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code LGZ·February 20, 2012

    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code BYG·April 26, 2011

    Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DXQ·April 26, 2011

    Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code OGL·October 17, 2011

    GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·June 12, 2012

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code HGP·October 16, 2012

    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code KAK·August 17, 2012

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code FLL·July 18, 2013

    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSF·September 19, 2013

    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code CAH·December 26, 2013

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021