7 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 2016
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·April 24, 2019
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 27, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 6, 2025
Ventilator HAMILTON-C6, PN: 160021
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·June 26, 2024
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 31, 2022
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
FDA Enforcement
Class I
·Terminated·Hamilton Medical AG·July 17, 2019