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

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    SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029042403·4 Bicuspid Extraction w/Seating Springs

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970355·

    FOOTPRINT MEDICAL SILICONE FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NEXTAR INFRARED CAMERA

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 26, 2013

    REDUCTION SPOON 9MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·October 2, 2008

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    SPECTRA OPTIA

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·April 21, 2020

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·August 22, 2018