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

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    iTClamp50

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGXO

    FDA UDI
    Oticon A/S·05707131281555·H150V2, BTE 13 WL 85 DBL AGXO

    QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABC 2 SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIO·June 6, 2013

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 21, 2011

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    FDA Adverse Event
    Malfunction ·MENTOR TEXAS·Product code LCJ·October 20, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·May 24, 2022

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·June 27, 2024

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·December 9, 2022

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018