Trudell Medical International
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | January 15, 2025 |
| K203400 | Corrugated tube with mouthpiece accessory | June 14, 2021 |
| K200063 | AeroEclipse* ONE BAN | July 17, 2020 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | August 16, 2019 |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | January 11, 2019 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | August 17, 2018 |
| K173825 | MC 300R* Nebulizer | May 2, 2018 |
| K173367 | MC 300* Nebulizer | February 28, 2018 |
| K150173 | Aerobika OPEP Devive with Manometer | October 15, 2015 |