BEUDAMED
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    POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743595·LEVAMED ANKLE SUPPORT SAND II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743717·ACHIMED ACHILLES SUPP SAND II

    FITLIFE

    FDA UDI
    Respironics, Inc.·00606959023000·FitLife with Lab Headgear Lab Mask, Large, USA

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481475876·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

    EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SELOX SR 60

    FDA Adverse Event
    BIOTRONIK SE & CO. KG·Product code NVN·April 16, 2013

    ALLURA XPER FD10C

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·March 11, 2011

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·June 12, 2008

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022