BEUDAMED
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    GYRUS OPEN FORCEPS

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

    Truliant

    FDA UDI
    Exactech, Inc.·10885862595492·

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 14, 2021

    MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES

    FDA 510(k)
    FDA Class 2 ·Radiology

    SALUTE, MODEL 3022

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

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 27, 2013

    VERSA DR

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code NVZ·March 18, 2011

    DORADO PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·March 27, 2008

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DTK·August 31, 2017

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012