Aerogen Ltd.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0121-2015 | Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that | September 2, 2014 |
| Z-0119-2015 | Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that | September 2, 2014 |
| Z-0118-2015 | Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that | September 2, 2014 |
| Z-0120-2015 | Class II | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that | September 2, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | September 2, 2025 |
| K232507 | Aerogen®Solo Nebulizer System | May 10, 2024 |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | October 17, 2014 |
| K120939 | AERONEB PRO | April 26, 2012 |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATI | May 13, 2011 |
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 | November 21, 2003 |
| K021175 | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 | May 15, 2002 |
| K003022 | AERONEB PORTABLE NEBULIZER | October 13, 2000 |
| K992831 | AERONEB II, MODEL APN 200 | August 25, 2000 |