BEUDAMED
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    IQ NASAL MASK, MODEL 50160 REV. D

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189799·LEVAMED ACTIVE ANKLE SUP BLACK R IV

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310215343·FG Diamond 856-016 round end taper extra coarse...

    T-cone

    FDA UDI
    Haag-Streit AG·07640132986532·

    Midmark

    FDA UDI
    MIDMARK CORPORATION·00841709109539·Midmark LED retrofit kit to bring the performan...

    EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PINNACLE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013

    ENDOSCOPIC BILIARY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQR·March 17, 2011

    6461500 INFUSOR PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·March 26, 2008

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014