BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    Aquarius Stoma Measuring Device

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

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054977·

    Acetabular Reamers

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039004·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121522460·Bridgeback Acetabular Reamer, Size 46mm

    MODIFICATION TO EN-BLOC BIOPSY SYSTEM

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

    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 7, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 23, 2011

    TYCO HEALTHCARE AUTOSUTURE

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL CORP. (COVIDIEN)·Product code GDW·August 13, 2008

    MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    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