Trudell Medical Intl. FDA Record
Trudell Medical Intl. has 0 FDA recalls, 0 inspections, 12 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Trudell Medical Intl." is on file.
- Latest 510(k)
- Oct 24, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 12 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Oct 24, 2013 |
| K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE | May 16, 2013 |
| K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) | Mar 11, 2013 |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) | Jul 11, 2012 |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Apr 18, 2011 |
| K090065 | AEROCHAMBER MINI VENTILATION CHAMBER | Apr 9, 2009 |
| K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER | Aug 12, 2008 |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR | Apr 11, 2007 |
| K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER | Feb 27, 2006 |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Sep 21, 2005 |
| K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER | Jan 14, 2004 |
| K012368 | AEROPEP | Feb 12, 2002 |
Trudell Medical Intl. and the FDA: common questions
Has Trudell Medical Intl. received an FDA warning letter?
No FDA warning letter addressed to the name "Trudell Medical Intl." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Trudell Medical Intl. received an FDA Form 483?
FDA has not published a Form 483 for "Trudell Medical Intl." in its reading room. FDA publishes some Form 483s, not all of them.
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