BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    ETEST FOR GEMIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    3M™ Unitek™ SmartClip™ MBT™

    FDA UDI
    3m do Brasil Ltda.·00652221003294·SmartClip(TM) Self-Ligating Bracket MBT(TM) LL4...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809873122·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NO STEP ON SITE DEUG TEST CUP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

    TRIAGE D-DIMER TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 9, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

    CONTAK RENEWAL 3 RF HE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 7, 2013