Southwest Technologies Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 5
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2109-2021 | Class II | Stimulen Collagen Moisturizing Lotion, ST9555B | May 28, 2021 |
| Z-0687-2020 | Class II | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 | November 18, 2019 |
| Z-1600-2018 | Class II | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP6 | December 28, 2017 |
| Z-1602-2018 | Class II | HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), | December 28, 2017 |
| Z-1601-2018 | Class II | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM | December 28, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING | November 3, 2010 |
| K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING | July 30, 2009 |
| K030774 | STIMULEN COLLAGEN | August 9, 2004 |
| K872488 | ELASTO-GEL CAST & SPLINT PADS | September 21, 1987 |
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING | June 26, 1987 |