BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304007475·

    AGXO

    FDA UDI
    Oticon A/S·05707131282927·H110V2, BTE 13 WL 100 CBE AGXO

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099423·Procera Implant Bridge Ti Abut Level 4 unit

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103881·T³ Acetabular Hemispherical Shell, No Hole, 46mm

    STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PAINACEA MODEL XR8 INFRARED HEAT LAMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECTRONIC GAS BLENDER

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025

    STOCKERT S3 GAS BLENDER

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 6, 2013

    TOTAL ASR FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

    S3 GAS BLENDER SYSTEM

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

    S3 GAS BLENDER SYSTEM

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

    S3 ELECTRONIC GAS BLENDER

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024

    SORIN S3 GAS BLENDER

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024