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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.

    FDA Enforcement
    Class II ·Terminated·Otto Bock Healthcare Product·September 2, 2015

    Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·March 9, 2016

    Nussloch GmbH ASP6025 Tissue Processor

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·July 12, 2017

    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

    FDA Enforcement
    Class II ·Terminated·TEM Systems Inc·April 15, 2015

    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·January 27, 2016

    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

    FDA Enforcement
    Class II ·Ongoing·GETINGE US SALES LLC·December 18, 2019

    TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·October 2, 2013

    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 29, 2015

    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·May 24, 2017