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

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRX-Transportable System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971021281·DRX-TRANS/FIELDPORT-DRX-1&-1CW/30DAYWAR

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 7, 2020

    POWDER-FREE NITRILE EXAM GLOVE, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHYSICA KR TIB. LINER RIGHT #7

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code MBH·December 19, 2022

    3M PARTICULATE RESPIRATOR AND SURGICAL MASK

    FDA Adverse Event
    Malfunction ·3M HEALTH CARE·Product code FXX·March 22, 2013

    BHR ACETABULAR CUP 56MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 25, 2008

    TRULIANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 31, 2023

    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 Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    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