Company ยท CA
Trudell Medical International
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2025 | K242667 | AeroChamber2go Anti-Static Valved Holding Chamber Trudell Medical International, CA | NVP |
| Jun 14, 2021 | K203400 | Corrugated tube with mouthpiece accessory Trudell Medical International, CA | CAF |
| Jul 17, 2020 | K200063 | AeroEclipse* ONE BAN Trudell Medical International, CA | CAF |
| Aug 16, 2019 | K183108 | Combined Aerobika OPEP and VersaPAP device Trudell Medical International, CA | BWF |
| Jan 11, 2019 | K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International, CA | NVP |
| Aug 17, 2018 | K173918 | VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International, CA | BWF |
| May 2, 2018 | K173825 | MC 300R* Nebulizer Trudell Medical International, CA | CAF |
| Feb 28, 2018 | K173367 | MC 300* Nebulizer Trudell Medical International, CA | CAF |
| Oct 15, 2015 | K150173 | Aerobika OPEP Devive with Manometer Trudell Medical International, CA | BWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||