BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150500·Endo Carry-on Procedure Kit Includes Intercept ...

    VIvid NuFil Syringe bleach

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724D0104720·

    GCX- Vivo 45 Series Trolley

    FDA UDI
    Breas Medical AB·07321820104727·GCX Trolley for Vivo 45 Series

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008116·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0104020·Caddie, Large, 30mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0104020·Caddie, Large, 30mm

    HA PARTICLES

    FDA Adverse Event
    Other ·CALCITEK·Product code MBE·February 7, 1997

    NA

    FDA UDI
    STRYKER CORPORATION·04546540348449·U Series Elite Long Angled Attachment

    POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POSI-LINK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 15, 2015

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 11, 2007

    BAUSCH + LOMB IOL INJECTOR

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·March 14, 2013

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·August 14, 2014

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 15, 2015

    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