111 results
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31ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Albert Hohlkörper GmbH & Co. KG
Importer
🇩🇪 Germany·3 Manufacturers
TROGE Medical GmbH
Importer
🇩🇪 Germany·11 Manufacturers
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Enforcement
Class II
·Terminated·AAP Implantate Ag·April 15, 2020
Power Express, REF B90918
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
PE Centrifuge, REF: B36365, a component of the Power Express
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·September 11, 2024
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
FDA Enforcement
Class II
·Ongoing·Seca·March 11, 2020
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
FDA Enforcement
Class II
·Terminated·Brainlab AG·February 14, 2018
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
FDA Enforcement
Class II
·Ongoing·Maquet Cardiopulmonary Gmbh·February 11, 2026
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Enforcement
Class II
·Terminated·Abbott GmBH & Co. KG·December 4, 2019
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
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024
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
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
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018