BEUDAMED
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    ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

    MedGyn Uterine Curette

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803022209·9mm rigid straight curette

    Cook

    FDA UDI
    COOK INCORPORATED·00827002158030·Whistle Tip Ureteral Catheter

    CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GE MARQUETTE ECG ANALYSIS PROGRAM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF022209854633217201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF0222098546338117201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF022209854632517201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF0222098546312717201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF022209854631317201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF0222098546315917201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF0222098546312017201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF022209854631217201·BTE-TRT

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF0222098546338217201·BTE-TRT

    ONCOZENE MICROSPHERES

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRD·August 4, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 11, 2011

    SPEEDBAND SUPER VIEW SUPER 7

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·March 26, 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