BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    DB-Orthopedics

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Shannon Recta Larga Round Shank

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613289600·

    McINDOE DRESSING/TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896061293·McINDOE DRESSING/TISSUE FORCEPS CROSS SERRATIONS

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055599·METZENBAUM SCISSORS CURVED TENOTOMY TIP BLADES ...

    VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596

    FDA 510(k)
    FDA Class 2 ·Immunology

    RHIGENE MESACUP2 TEST- RNP

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·October 24, 2014

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·July 27, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 1, 2013

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

    STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

    UNK - CONSTRUCTS: EXPEDIUM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·September 7, 2021

    UNK - CONSTRUCTS: EXPEDIUM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·September 7, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021