BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Rainbow Shine

    FDA 510(k)
    FDA Class 2 ·Dental

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304674943·

    GREEN LOVE MALE CONTRACEPTIVE (CONDOM)

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

    ACIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD WHITACRE SPINAL NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code BSP·March 27, 2007

    OSS NON-MOD PROX TIB 7CM15X150

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·June 6, 2019

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 7, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 6, 2011

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

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

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