Trudell Medical I N T

FDA Filings

This page includes the latest FDA filings for Trudell Medical I N T. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9612777
FEI Number3001610754
NameTRUDELL MEDICAL INTL.
Owner & OperatorTRUDELL MEDICAL INTL
Contact Address725 Baransway Drive, --
LONDON CA-ON Ontario N5V 5G4 CA
Official Correspondent
  • Marianne Tanton
  • 1-519-4557060-2205
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address725 Baransway Drive
LONDON Ontario, N5V 5G4 CA
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Trudell Medical International
AeroEclipse® ONE Breath Actuated Nebulizer Disposable 2020-08-11
Trudell Medical International
AeroEclipse* ONE BAN2020-07-17
Trudell Medical International
AEROBIKA OPEP Manometer 2020-04-30
Trudell Medical International
AEROCHAMBER mini Holding Chamber 875940102020-04-23
Trudell Medical International
VersaPAP™ Positive Airway Pressure Device 121501941002020-04-23
Trudell Medical International
VersaPAP™ Positive Airway Pressure Device 121501940102020-04-23
Trudell Medical International
RespiConnect* Adapter 112501940402020-04-23
Trudell Medical International
AEROBIKA OPEP with Manometer 110504940102020-04-23
Trudell Medical International
AEROBIKA OPEP Manometer 110502940252020-04-23
Trudell Medical International
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System 110501941002020-04-23
Trudell Medical International
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System 110501940102020-04-23
Trudell Medical International
MC 300*R Nebulizer with Mouthpiece 105552940502020-04-23
Trudell Medical International
MC 300 Nebulizer with Mouthpiece 105550940502020-04-23
Trudell Medical International
OMBRA Compressor Air Filters 105544940012020-04-23
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing 105541940502020-04-23
Trudell Medical International
EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN 105514940102020-04-23
Trudell Medical International
AEROECLIPSE* XL Reusable Breath Actuated Nebulizer 105513940502020-04-23
Trudell Medical International
AeroEclipse* XL Breath Actuated Nebulizer 105510940062020-04-23
Trudell Medical International
OMBRA 120V Table Top Compressor System 105510940062020-04-23
Trudell Medical International
AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator 105507940102020-04-23
Trudell Medical International
AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable 105506940502020-04-23
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter 105505940502020-04-23
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer Disposable 105501940502020-04-23
Trudell Medical International
AEROECLIPSE BAN Replacement Mouthpiece Assembly 105509940802020-04-01
Trudell Medical International
MC 300* Nebulizer with Universal Tubing 2020-02-27
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing 2020-02-27
Trudell Medical International
VersaPAP™ Positive Airway Pressure Device 2020-02-27
Trudell Medical International
RespiConnect* Adapter 112501940402020-02-27
Trudell Medical International
AEROECLIPSE XL Reusable Breath Actuated Nebulizer 2020-02-27
Trudell Medical International
EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN 2020-02-27
Trudell Medical International
AEROBIKA OPEP with Manometer 2020-02-26
Trudell Medical International
AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable 2020-02-26
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter 2020-02-26
Trudell Medical International
AEROCHAMBER mini Holding Chamber 2020-02-26
Trudell Medical International
AEROBIKA Oscillating Positive Expiratory Pressure Therapy System 2020-02-26
Trudell Medical International
MC 300® Reusable Nebulizer 2020-02-26
Trudell Medical International
MC 300 Nebulizer with Mouthpiece 2020-02-26
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer Disposable 2020-02-26
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing 2020-01-13
Trudell Medical International
AEROTRACH PLUS Anti-Static Valved Holding Chamber 2020-01-13
Trudell Medical International
AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing 105542940502020-01-06
Trudell Medical International
AEROTRACH PLUS Anti-Static Valved Holding Chamber 101505940102020-01-06
Trudell Medical International
VersaPAP® Positive Airway Pressure Device 2019-11-13
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Combined VersaPAP device and Aerobika OPEP2019-08-26
Trudell Medical International
Combined Aerobika OPEP And VersaPAP Device2019-08-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber2019-01-14
Trudell Medical International
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)2019-01-11
Trudell Medical International
VersaPAP Positive Airway Pressure (PAP) Device2018-08-17
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
VersaPAP* Positive Airway Pressure (PAP) Device2018-08-17
Trudell Medical International
MC 300R* Nebulizer2018-05-02
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
MC 300*R Nebulizer2018-05-02
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Altimate High Altitude Sleep Mask2018-03-27
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
MC 300 Nebulizer2018-03-07
Trudell Medical International
MC 300* Nebulizer2018-02-28
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Abilex* Oral Motor Exerciser2017-10-13
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Aerobika OPEP with Manometer2015-12-21
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
RespiConnect Adapter2015-12-21
Trudell Medical International
Aerobika OPEP Devive With Manometer2015-10-15
TRUDELL MEDICAL INT'L
RESPICONNECT ADAPTER2014-08-15
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Ombra Table Top Compressor2014-01-10
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Solarys Ventilator Aerosol Delivery System2013-05-22
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
Aerobika Oscillating Positive Expiratory Pressure Device2013-05-22
TRUDELL MEDICAL INTL.
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE2013-05-16
TRUDELL MEDICAL INTL.
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)2013-03-11
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber Plus* Flow-Vu* Anti-Static VHC2012-08-15
TRUDELL MEDICAL INTL.
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)2012-07-11
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
RespiChamber Valved Holding Chamber2011-05-10
TRUDELL MEDICAL INTL.
RESPICHAMBER VALVED HOLDING CHAMBER2011-04-18
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber Plus VHC2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber mini Holding Chamber2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber mini Aerosol Chamber2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroEclipse Reusable BAN2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber Z-Stat Plus VHC2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber MAX VHC2009-04-16
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroTrach Plus anti-static Valved Holding Chamber2009-04-16
TRUDELL MEDICAL INTL.
AEROCHAMBER MINI VENTILATION CHAMBER2009-04-09
TRUDELL MEDICAL INTL.
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER2008-08-12
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroChamber Plus Anti-Static VHC2008-03-31
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
AeroEclipse II BAN2008-03-31
TRUDELL MEDICAL INTL.
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR2007-04-11
TRUDELL MEDICAL INTL.
AEROECLIPSE II BREATH ACTUATED NEBULIZER2006-02-27
TRUDELL MEDICAL INTL.
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER2005-09-21
TRUDELL MEDICAL INTL.
AEROCHAMBER MAX VALVED HOLDING CHAMBER2004-01-14
TRUDELL MEDICAL INTL.
AEROPEP2002-02-12
TRUDELL MEDICAL INTL. [TRUDELL MEDICAL INTL]
MASK ASSEMBLY2001-05-03
TRUDELL MEDICAL INT'L
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)2000-07-05
TRUDELL MEDICAL INT'L
AEROCHAMBER PLUS VALVED HOLDING CHAMBER1999-09-14

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