57 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
FDA Recall
Open, Classified
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code PGW·April 4, 2024
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
FDA Recall
Open, Classified
·Ambu Inc.·Product code EOQ·April 7, 2025
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
FDA Recall
Open, Classified
·Genicon, Inc.·Product code GEA·August 21, 2018
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 515304
FDA Recall
Open, Classified
·Becton Dickinson & Company·Product code ONB·July 18, 2022
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
FDA Recall
Open, Classified
·Canon Medical System, USA, INC.·Product code LNH·December 19, 2025
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
FDA Recall
Open, Classified
·Canon Medical System, USA, INC.·Product code LNH·December 19, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Recall
Open, Classified
·IMPRIS Imaging Inc·Product code LNH·September 30, 2025