Panels › Anesthesiology › Product code CCW · Class 1
Laryngoscope, Rigid
Regulation 868.5540
0510(k)s in 12 months (64 all time)
0recalls in 12 months (53 all time)
2recalls that name a 510(k)
Top companies in CCW
| Company | 510(k)s | Recalls |
|---|---|---|
| TELEFLEX MEDICAL INC | 0 | 16 |
| Verathon Inc | 0 | 12 |
| Covidien | 0 | 6 |
| Flexicare Medical (Dongguan) Ltd. | 0 | 6 |
| Augustine Medical, Inc. | 5 | 0 |
| Eastmed Enterprises, Inc. | 5 | 0 |
| Minrad, Inc. | 3 | 0 |
| Flexicare Medical Ltd. | 0 | 2 |
| Michael S. Upsher | 2 | 0 |
| Penlon , Ltd. | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Single-Use Fiber Optic Laryngoscope Handle
Refs:040-310AU and 040-310U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle
REF:040-309U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle
REF:040-03-0000U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Mini with Pro Miller Blade Size 1.5,
REF:040-02-0415U Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Single-Use Fiber Optic Handle and Blade
Refs:
040-331U (Mac 1),
040-332U (Mac 2),
040-333U (Mac 3),
040-335U (Mac 3.5)
040-334U (Mac 4),
040-341U (Miller 1),
040-342U (Miller 2),
040 Open, Classified |
CCW | None listed |
| Aug 1, 2025 | Flexicare Medical (Dongguan) Ltd. BritePro Solo Single-Use Fiber Optic Mini Handle and Blade
Ref:
040-02-0110U (Mac 1),
040-02-0120U (Mac 2),
040-02-0130U (Mac 3),
040-02-0131U (Mac 3 Strong Curve)
040-02-0140U (Mac 4),
040-02-0400 Open, Classified |
CCW | None listed |
| Jul 11, 2025 | Intersurgical Inc i-view video laryngoscope. Model Number: 8008000.
The i-view video laryngoscope is indicated to facilitate laryngoscopy. Open, Classified |
CCW | None listed |
| Aug 22, 2024 | Covidien Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly Open, Classified |
CCW | None listed |
| Aug 21, 2024 | Covidien McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only Open, Classified |
CCW | None listed |
| Aug 21, 2024 | Covidien McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only Open, Classified |
CCW | None listed |
| 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 |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D Open, Classified |
CCW | None listed |
| Nov 2, 2023 | Covidien Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 Open, Classified |
CCW | None listed |
| Nov 1, 2023 | Covidien McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only Open, Classified |
CCW | None listed |
| Nov 1, 2023 | Covidien McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only Open, Classified |
CCW | None listed |
| May 17, 2022 | Baxter Healthcare Corporation #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED Terminated |
CCW | None listed |
| Jul 1, 2021 | Verathon, Inc. GlideScope Go Monitors Open, Classified |
CCW | None listed |
| Feb 18, 2021 | TELEFLEX MEDICAL INC RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation. Terminated |
CCW | None listed |
| 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 |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551035
GTIN:7290102156443 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tr Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551004
GTIN: 24026704553796 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551003
GTIN: 14026704663122 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004551002
GTIN: 14026704663115 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004550004
GTIN: 14026704663085 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 0004550003
GTIN: 14026704663078 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Jul 6, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Product Code: 004550002
GTIN: 14026704663061 (each) - Product Usage:
The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during Terminated |
CCW | None listed |
| Feb 10, 2020 | Medtronic, PLC McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea
Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Pro Open, Classified |
CCW | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System Terminated |
CCW | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System Terminated |
CCW | None listed |
| Feb 4, 2020 | King Systems Corp. dba Ambu, Inc. King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube.
Model Number: KVLVA12 Terminated |
CCW | None listed |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783
The device is intended for direct vision laryngoscopy to obtain Terminated |
CCW | None listed |
| Jan 13, 2020 | Flexicare Medical Ltd. BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001
The device is intended for direct vision laryngoscopy to obtain an Terminated |
CCW | None listed |
| Mar 31, 2019 | Verathon, Inc. GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 Terminated |
CCW | None listed |
| Feb 23, 2018 | Teleflex Medical Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation. Terminated |
CCW | None listed |
| Jul 13, 2017 | Bomimed BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box.
The rigid laryngoscope handle is a device used along with a blad 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 |
| 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 |
| Dec 2, 2014 | Aircraft Medical Limited McGrath MAC2 Video Laryngoscope Blades
Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized.
Product Usage: Single Use, sterile video laryngoscope blade for use wi Terminated |
CCW | None listed |
| Jul 29, 2014 | Teleflex Medical RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical. Terminated |
CCW | None listed |
| Jul 26, 2014 | Teleflex Medical Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. Terminated |
CCW | None listed |
| Nov 20, 2013 | Teleflex Medical Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. 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 |
| Mar 18, 2012 | Penlon, Ltd. Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI)
Product Usage: Disposable laryngoscope blades. Terminated |
CCW | None listed |
| Sep 14, 2011 | Penlon, Ltd. (Fmly East Healthcare) Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647
Disposable laryngoscope blades Terminated |
CCW | None listed |
| Feb 2, 2011 | Vital Signs Colorado Inc. Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112.
Used for tracheal tube intubations during anesthesia, inte Terminated |
CCW | None listed |
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