Imagyn Medical Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR | September 4, 2003 |
| K012706 | IM2001 PULSE OXIMETER | March 7, 2003 |
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | December 3, 2001 |
| K991526 | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 | June 17, 1999 |
| K980096 | OAC (OPTICAL ASPIRATING CURETTE) | May 1, 1998 |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | March 11, 1998 |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | February 25, 1998 |