BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)

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

    Inspire™ Esthetic Provisional Composite A2

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010511·Esthetic Provisional Composite

    Inspire™ Esthetic Provisional Composite A2

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003944·Esthetic Provisional Composite

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055752·

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124573·Modular Offset Stem 17mm x 100mm x 2mm

    BD BBL¿ LEVINE EMB AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·August 6, 2021

    BD BBL¿ LEVINE EMB AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·August 25, 2021

    MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY

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

    IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER® URINE COMPLETE CUP KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·June 19, 2019

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    MEDTRONIC.SIGMA

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014