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

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    First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    S4 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    BD PEGASUS YEL 24GAX0.75IN PRN-CAPY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·November 16, 2021

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 7, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 4, 2022

    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023