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

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    Filters Classification: Class Ii × Country: Germany × Clear all

    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

    FDA Enforcement
    Class II ·Terminated·Richard Wolf GmbH·August 18, 2021

    SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.

    FDA Enforcement
    Class II ·Terminated·Hager & Meisinger Gmbh·September 16, 2020

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 18, 2017

    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile

    FDA Enforcement
    Class II ·Ongoing·Peter Lazic Gmbh·March 20, 2024

    CombiDiagnost R90 Software Version R1.0 and R1.1

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024

    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·March 19, 2014

    L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile

    FDA Enforcement
    Class II ·Ongoing·Peter Lazic Gmbh·March 20, 2024

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 14, 2019

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    FDA Enforcement
    Class II ·Ongoing·LivaNova Deutschland GmbH·December 4, 2024

    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.

    FDA Enforcement
    Class II ·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 5, 2019

    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 30, 2015

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Enforcement
    Class II ·Terminated·Leoni Fiber Optics GmbH·December 19, 2018

    Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Enforcement
    Class II ·Terminated·Leoni Fiber Optics GmbH·December 19, 2018

    Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Enforcement
    Class II ·Terminated·Leoni Fiber Optics GmbH·December 19, 2018