BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    DSM Biomedical Calcium Phosphate Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025071·T47 Warming Plate

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198213·Bergstrom SMBN Skeletal Muscle Biop

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020140·INTRG WHISP-Z ROTH CUS-11T +5A 018 LL

    Cooley Ring-Bulldog Clamp str. 13cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034060742·Cooley Ring-Bulldog Clamp str. 13cm

    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FlexSys

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

    UNKNOWN DEPUY FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code KWY·November 6, 2014

    ASR 300 SPIKED CUP SIZE 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·August 31, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 16, 2013

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024