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

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    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

    FDA Enforcement
    Class II ·Terminated·Sutter Medizintechnik GmbH·August 12, 2020

    ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·September 25, 2024

    ViewPoint; system, imaging processing, radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·September 25, 2024

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·March 27, 2019

    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·April 1, 2015

    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

    RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The 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.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·May 1, 2019

    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    FDA Enforcement
    Class II ·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016

    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·February 13, 2019

    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

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    FDA Enforcement
    Class II ·Terminated·Pro-Med Instruments Gmbh·December 13, 2017

    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

    Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 23, 2020

    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 12, 2019

    Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·August 29, 2018

    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)

    FDA Enforcement
    Class II ·Ongoing·PTW-FREIBURG·September 20, 2023

    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 4, 2013

    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