BEUDAMED
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    Elecsys Anti-TSHR

    FDA 510(k)
    FDA Class 2 ·Immunology

    AGXO

    FDA UDI
    Oticon A/S·05707131342225·G100, BTE 13 2.4G 85 C063 AGXO

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198185·AK3 PS Insert Trial Size 3, 13mm

    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYNERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Injury ·COOK INC·Product code JOH·January 24, 2022

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 20, 2014

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 13, 2011

    CERTAIN® 3.4MM(D) DRIVER TIP - SHORT

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NDP·May 30, 2017

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Injury ·COOK INC·Product code JOH·January 24, 2022

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·May 11, 2022

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·July 17, 2023

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·July 17, 2023

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·May 28, 2024

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·June 21, 2024

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·January 15, 2025

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code JOH·January 14, 2022