BEUDAMED
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    GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DRX - Ascend System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971021809·DRX-ASCEND SYSTEM/QG-50-2-R10-T920V

    TISSUE MARKER

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

    SCS CLARIS SPINAL SCREWS, TYPES V,G,E

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTO ENDO5 ML

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·August 8, 2017

    PHILOS II DR

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·March 26, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 25, 2011

    UNIFY ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·August 19, 2014

    REFLECTION CONSTRAINED ACETABULAR LINER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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