45 results
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25ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Enforcement
Class II
·Ongoing·3M Company - Health Care Business·February 28, 2024
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Enforcement
Class II
·Ongoing·3M Company - Health Care Business·February 28, 2024
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
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
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
microTargeting" Drive System, Product Number MT-DS-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number 66-ZD-MD
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018