BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    STRATUS CS TROPONIN I CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122330·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517276520·CoRoent Large MP, 10x9x23mm 12°

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve

    BVI SLING

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

    POWDER FREE NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTORNIC NAVIGATION, INC.·Product code HAW·February 2, 2011

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    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