Company ยท US
Verathon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2017. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
19recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2017 | K172356 | BladderScan Prime PLUS System Verathon Incorporated | IYO |
| Nov 19, 2015 | K153101 | BladderScan Prime System Verathon Incorporated | IYO |
| Mar 13, 2009 | K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND Verathon Incorporated | IYO |
| Dec 1, 2008 | K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 Verathon Incorporated | IYO |
| May 17, 2007 | K071217 | BLADDERSCAN BVI 9400 ULTRASOUND Verathon Incorporated | IYO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2024 | Verathon, Inc. 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 Open, Classified |
CCW | None listed |
| Jun 4, 2024 | Verathon, Inc. Brand Name: GlideScope Core 15-inch Monitor
Model/Catalog Number: 0570-0404
Product Description: Serialized Monitor Open, Classified |
CCW | None listed |
| Jul 1, 2021 | Verathon, Inc. GlideScope Go Monitors Open, Classified |
CCW | None listed |
| Sep 29, 2020 | Verathon, Inc. BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively. Terminated |
ITX | K172356 |
| Jul 10, 2020 | Verathon, Inc. GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System
Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with t Terminated |
CCW | None listed |
| Mar 31, 2019 | Verathon, Inc. GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 Terminated |
CCW | None listed |
| Apr 18, 2017 | Verathon Inc 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 Terminated |
CCW | None listed |
| Mar 11, 2016 | Verathon, Inc. GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Sm Terminated |
CCW | None listed |
| Dec 15, 2015 | Verathon, Inc. 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 so Terminated |
CCW | None listed |
| Dec 15, 2015 | Verathon, Inc. 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 La Terminated |
CCW | None listed |
| Nov 30, 2015 | Verathon, Inc. 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. Terminated |
IYO | K082456 |
| Jul 13, 2015 | Verathon, Inc. 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 Terminated |
CCW | None listed |
| Jun 20, 2013 | Verathon, Inc. GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades
Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical profession Terminated |
CCW | None listed |
| Dec 7, 2012 | Verathon, Inc. The GlideScope Video Laryngoscope (GVL) 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 moni Terminated |
CCW | None listed |
| Oct 26, 2010 | Verathon, Inc. The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..." Terminated |
ITX | K022153 K030763 |
| Oct 4, 2010 | Verathon, Inc. BladderScan BVM 9500
The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasi Terminated |
IYO | K090214 |
| Oct 4, 2010 | Verathon, Inc. AortaScan AMI 9700
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements Terminated |
IYO | K082456 |
| Oct 4, 2010 | Verathon, Inc. BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the l Terminated |
IYO | K082456 |
| Sep 17, 2009 | Verathon, Inc. The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bla Terminated |
IYO | K071217 |