ASI Medical, Inc.
FDA Regulatory Profile
ASI Medical, Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 3 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-0545-2014, Class II) was initiated on November 5, 2013. Its most recent 510(k) clearance was granted on March 28, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0545-2014 | Class II | SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained de | November 5, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | March 28, 2013 |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | April 5, 2012 |
| K974488 | AIRPREP SYSTEM - MODEL 9001 | May 26, 1998 |
| K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | February 18, 1998 |
| K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | March 7, 1994 |