7 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 30, 2023
Ultrasonic Bronchoscope BF-UC160F-OL8
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 10, 2018
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 9, 2020
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc·February 5, 2020
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc·February 5, 2020