Company ยท CA
Trudell Medical Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2013. Name variants (Inc, Corp, punctuation) are merged.
12510(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 |
|---|---|---|---|
| Oct 24, 2013 | K131881 | OMBRA TABLE TOP COMPRESSOR Trudell Medical Intl., CA | BTI |
| May 16, 2013 | K123400 | AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE Trudell Medical Intl., CA | BWF |
| Mar 11, 2013 | K123614 | SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) Trudell Medical Intl., CA | CAF |
| Jul 11, 2012 | K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) Trudell Medical Intl., CA | NVP |
| Apr 18, 2011 | K110136 | RESPICHAMBER VALVED HOLDING CHAMBER Trudell Medical Intl., CA | NVP |
| Apr 9, 2009 | K090065 | AEROCHAMBER MINI VENTILATION CHAMBER Trudell Medical Intl., CA | CAF |
| Aug 12, 2008 | K080926 | AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER Trudell Medical Intl., CA | CAF |
| Apr 11, 2007 | K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR Trudell Medical Intl., CA | NVP |
| Feb 27, 2006 | K053605 | AEROECLIPSE II BREATH ACTUATED NEBULIZER Trudell Medical Intl., CA | CAF |
| Sep 21, 2005 | K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER Trudell Medical Intl., CA | NVP |
| Jan 14, 2004 | K032972 | AEROCHAMBER MAX VALVED HOLDING CHAMBER Trudell Medical Intl., CA | CAF |
| Feb 12, 2002 | K012368 | AEROPEP Trudell Medical Intl., CA | BWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||