Somatex Medical Technologies GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1200-2021 | Class II | Thread-like wire marker | February 3, 2021 |
| Z-0410-2018 | Class II | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE | May 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | February 18, 2021 |
| K182082 | Tumark for Eviva, Tumark for Brevera | October 31, 2018 |
| K180443 | Tumark Vision | March 22, 2018 |
| K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | November 8, 2011 |
| K102771 | BIOPSY HANDY, MRI BIOPSY HANDY | June 24, 2011 |
| K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | February 17, 2010 |
| K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | March 19, 2008 |