BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CODE QAS.105 PROLACTIN CONTROL SERA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MGB Alert Enterovirus v.2.0 Primer Mix ASR, 48 rxns

    FDA UDI
    Elitechgroup Mdx LLC·03661540952104·DSQ Alert Enterovirus v2.0 Primer Mix is an ana...

    Tobii Dynavox

    FDA UDI
    TOBII DYNAVOX LLC·07340074601301·SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BL...

    Manta Ray TDF

    FDA UDI
    Seaspine Orthopedics Corporation·10889981290399·Modular Rasp, 20x15x8mm, 7 Deg

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810766·Hybrid Dual Taper Femoral Broach, Size 8

    NONE

    FDA Adverse Event
    Product code GKT·January 12, 2009

    PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VISION HOLLOW FIBER OXYGENATOR WITH HA COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEUKOTRAP WB, VENTED, 450ML, CP2D/AS3 WITH SDP-HQ

    FDA Adverse Event
    Death ·Product code GKT·January 22, 2009

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·May 27, 2021

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2015

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 4, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022