Atom Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1945-2012 | Class II | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, To | May 1, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123937 | ATOM TRANSCAPSULE V-707 | May 23, 2013 |
| K120937 | SUNFLOWER WARNER | July 6, 2012 |
| K111547 | BILI-THERAPY PAD TYPE | April 12, 2012 |
| K103317 | RESUSCITATION UNIT 105 | April 20, 2011 |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | April 6, 2011 |
| K103828 | BILI-THERAPY SPOT TYPE | March 29, 2011 |
| K102227 | INFA WARMER I | January 21, 2011 |
| K102226 | DUAL INCU I | January 4, 2011 |
| K102279 | INCU I | December 29, 2010 |
| K102710 | NEO-SERVO I | December 22, 2010 |