BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122300·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...

    ASIA MED

    FDA UDI
    asia-med GmbH·04251282509361·asia-med Kinesiology Tape - Dark Blue: made of...

    VaPro Pocket

    FDA UDI
    HOLLISTER INCORPORATED·00610075052974·No Touch Urethral Intermittent Catheter, Hydrop...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011491·PedFuse Respond, CNL, 6.0mm x 30mm

    BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 12, 2024

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1

    PORTABLE INTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FLASH

    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

    FIRST PICC

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code FOZ·February 2, 2011

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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