Medical Device Manufacturer · CA , London

Trudell Medical International

9 submissions · 9 cleared · Since 2015
9
Total
9
Cleared
0
Denied

Trudell Medical International — FDA 510(k) Submissions

Trudell Medical International has submitted 9 FDA 510(k) premarket notifications since 2015, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nebulizer (direct Patient Interface), Spirometer, Therapeutic (incentive), Holding Chambers, Direct Patient Interface . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
AeroChamber2go Anti-Static Valved Holding Chamber
K242667 · NVP Holding Chambers, Direct... · Anesthesiology
Jan 2025 132d
Corrugated tube with mouthpiece accessory
K203400 · CAF Nebulizer (direct Patient... · Anesthesiology
Jun 2021 207d
AeroEclipse* ONE BAN
K200063 · CAF Nebulizer (direct Patient... · Anesthesiology
Jul 2020 186d
Combined Aerobika OPEP and VersaPAP device
K183108 · BWF Spirometer, Therapeutic... · Anesthesiology
Aug 2019 281d
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
K181649 · NVP Holding Chambers, Direct... · Anesthesiology
Jan 2019 203d
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · BWF Spirometer, Therapeutic... · Anesthesiology
Aug 2018 238d
MC 300R* Nebulizer
K173825 · CAF Nebulizer (direct Patient... · Anesthesiology
May 2018 135d
MC 300* Nebulizer
K173367 · CAF Nebulizer (direct Patient... · Anesthesiology
Feb 2018 125d
Aerobika OPEP Devive with Manometer
K150173 · BWF Spirometer, Therapeutic... · Anesthesiology
Oct 2015 262d
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