BEUDAMED
    26 results · 29ms · Sources: EU EUDAMED, US FDA

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    SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

    FDA 510(k)
    FDA Class 2 ·Dental

    SiVIEW Dongle DVI-CAN-01

    Device
    EU MDR · Eu Md Class 1 ·SiVIEW·On the market

    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.

    FDA Enforcement
    Class II ·Terminated·Normand-Info S.A.S.U.·August 12, 2020

    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    FDA Enforcement
    Class II ·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025

    Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

    FDA Enforcement
    Class II ·Terminated·Anthogyr·September 14, 2016

    Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

    FDA Enforcement
    Class II ·Terminated·Anthogyr·September 14, 2016

    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

    FDA Enforcement
    Class II ·Terminated·Medicrea International·November 25, 2020

    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·January 22, 2025

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Enforcement
    Class II ·Terminated·Imactis·March 24, 2021

    NucliSENS Lysis Buffer Extended lot for RES 76675

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·November 15, 2017

    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems

    FDA Enforcement
    Class II ·Terminated·Normand-Info S.A.S.U.·March 11, 2020

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    TD-Synergy. Laboratory Information System.

    FDA Enforcement
    Class II ·Terminated·Technidata S.A.·May 29, 2013

    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·NEOSTEO·August 18, 2021

    1st SurgiConcept

    Manufacturer
    🇫🇷 France·2 Basic UDI-DIs·2 Devices·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

    Caleçon jersey coton enfant taille 3-5 ans

    Device
    EU MDR · Eu Md Class 1 ·MAILL'TUB·On the market·31 countries

    Maillot jersey coton enfant taille 3-5 ans

    Device
    EU MDR · Eu Md Class 1 ·MAILL'TUB·On the market·31 countries

    Caleçons jersey coton enfant taille 6 mois à 2 ans

    Device
    EU MDR · Eu Md Class 1 ·MAILL'TUB·On the market·31 countries