BEUDAMED
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    EXEL VACULET BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160609·Channels Flex 21mm 30.04

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717107023·Gutta Percha Points, Taper .02, Size #30, 120pc...

    Excel™ Impression Material

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310205333·Safco light body fast set impression material

    SPECTRUM

    FDA Adverse Event
    Injury ·MECTA CORPORATION·Product code GXC·October 31, 2019

    SPECTRUM

    FDA Adverse Event
    Injury ·MECTA CORPORATION·Product code GXC·October 31, 2019

    SPECTRUM

    FDA Adverse Event
    Injury ·MECTA CORPORATION·Product code GXC·November 25, 2019

    VOCOM IMPLANT- 8MM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TCD 100M, PWD13 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    3020533-2019-00001

    FDA Adverse Event
    Injury ·March 20, 2019

    PRSVN ALLPOLY TIB LMRL S2 7MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·March 26, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·NELLCOR BENNETT CORP.·Product code CBK·February 10, 2011

    LUMAX 340 DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code MRM·March 28, 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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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