Ellman International, Inc.
FDA Regulatory Profile
Ellman International, Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0748-2017, Class II) was initiated on September 7, 2016. Its most recent 510(k) clearance was granted on February 20, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0748-2017 | Class II | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables, | September 7, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132949 | PELLEFIRM | February 20, 2014 |
| K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC | September 25, 2013 |
| K123366 | SURGITRON 4.0 DUAL RF S5-IEC | July 12, 2013 |
| K071343 | ELLMAN NOBLE ALLOY ELECTRODES | February 28, 2008 |
| K052241 | DISC-FX SYSTEM | February 24, 2006 |