BEUDAMED
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    LAURAIN DEWALD ANTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULMO-MIST COMPRESSOR MODEL # 4323

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACE AIM TTC FUSION NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EZ-28 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·March 26, 2013

    NI

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·March 10, 2011

    PRECISE RX NITINOL STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code FGE·April 1, 2008

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018