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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Country: Germany × Clear all

    9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·February 15, 2017

    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.

    FDA Enforcement
    Class II ·Terminated·WOM World of Medicine AG·December 5, 2018

    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 6, 2014

    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf GmbH·May 23, 2018

    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

    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf GmbH·August 5, 2020

    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    FDA Enforcement
    Class II ·Ongoing·PTW-FREIBURG·February 28, 2024

    ProxiDiagnost N90. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Enforcement
    Class II ·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020

    3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

    FDA Enforcement
    Class II ·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020

    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

    FDA Enforcement
    Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·May 1, 2024

    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·October 24, 2018

    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 25, 2015

    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

    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 20, 2014

    Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·April 23, 2014