BEUDAMED
    29 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO DUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20508401·Titanol S Spee-arches max. .016"

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508404·

    basixCOMPAK™

    FDA UDI
    Merit Medical Systems, Inc.·00884450022818·

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481475166·

    VITAL SCIENTIFIC PT WITH CALCIUM

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYNPLUG

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017

    MAXCEM ELITE CLEAR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 10, 2013

    SPL LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    CONCERTO CRT-D DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·April 12, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    FDA Enforcement
    Class I ·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·January 22, 2025

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    FDA Recall
    Open, Classified ·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·December 10, 2024