9 results
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11ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
FDA Enforcement
Class II
·Ongoing·Verathon, Inc.·June 12, 2024
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
FDA Enforcement
Class II
·Ongoing·Verathon, Inc.·June 12, 2024
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·February 24, 2016
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·March 18, 2020
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·December 23, 2015
GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·December 23, 2015
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·March 16, 2016
It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
FDA Enforcement
Class II
·Terminated·Verathon Inc·April 26, 2017
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
FDA Enforcement
Class II
·Terminated·Verathon, Inc.·December 9, 2020