Verathon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
14 (4 Class I)
510(k) Clearances
0
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2022-2024Class IIBrand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 April 29, 2024
Z-2021-2024Class IIBrand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: April 29, 2024
Z-2172-2021Class IIIGlideScope Go MonitorsJuly 1, 2021
Z-0531-2021Class IIBladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urSeptember 29, 2020
Z-2476-2020Class IGlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video LaryngoscJune 5, 2020
Z-1471-2020Class IIGlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03March 31, 2019
Z-1852-2017Class IIIt is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-04March 3, 2017
Z-1035-2016Class IGlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GliJanuary 29, 2016
Z-1091-2016Class IIBladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMNovember 30, 2015
Z-0420-2016Class IIGlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0November 30, 2015
Z-0421-2016Class IIGlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-November 30, 2015
Z-0811-2016Class IIGlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScoApril 13, 2015
Z-1558-2013Class IGlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades PMay 8, 2013
Z-0478-2013Class IThe GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution October 25, 2012