BEUDAMED
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    Allround Dental Apron RD639-SON for radiographs in a standing position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    Allround Dental Apron RD639-STD for radiographs in a standing position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    Protective Dental Apron RD642-STD for radiographs in a sitting position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    Protective Dental Apron RD642-SON for radiographs in a sitting position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    Protective Dental Apron RD635-SON for radiographs in a standing position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    Protective Dental Apron RD635-STD for radiographs in a standing position

    Device
    EU MDR · Eu Md Class 1 ·MAVIG GmbH·On the market

    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

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

    FDA Enforcement
    Class II ·Ongoing·Hager & Meisinger Gmbh·November 27, 2019

    WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01

    FDA Enforcement
    Class II ·Ongoing·WOM World Of Medicine AG·July 10, 2024

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    FDA Enforcement
    Class II ·Terminated·Stihler Electronic Gmbh·January 30, 2019

    Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    FDA Enforcement
    Class II ·Terminated·Stihler Electronic Gmbh·January 30, 2019

    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

    FDA Enforcement
    Class II ·Terminated·Stihler Electronic Gmbh·January 30, 2019

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

    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

    Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009

    FDA Enforcement
    Class II ·Ongoing·Seca·March 11, 2020

    Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.

    FDA Enforcement
    Class II ·Terminated·Otto Bock Healthcare GmbH·August 5, 2015

    B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

    FDA Enforcement
    Class II ·Ongoing·Brahms GmbH·April 15, 2026

    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: 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. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 24, 2019