BEUDAMED
    7 results · 38ms · Sources: EU EUDAMED, US FDA

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    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

    FDA Recall
    Terminated ·Childrens Medical Ventures·Product code FMP·May 28, 2014

    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

    FDA Recall
    Terminated ·Childrens Medical Ventures·Product code NPF·April 29, 2014

    Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

    FDA Recall
    Terminated ·Benlan, Inc.·Product code KYX·December 12, 2011

    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

    FDA Enforcement
    Class II ·Terminated·Childrens Medical Ventures·June 25, 2014

    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code FMP·October 10, 2014

    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

    FDA Enforcement
    Class I ·Terminated·Childrens Medical Ventures·August 27, 2014

    SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code FLS·April 23, 2009