Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSOUTHWEST TECHNOLOGIES, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1746 LEVEE RD., North Kansas City, MO, 64116
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1929833
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elasto-Gel | DR8600 | FDA UDI | U | Active |
| BioCol | AWC02 | FDA UDI | U | Active |
| Stimulen | ST9501 | FDA UDI | U | Active |
| BioCol | AWC01 | FDA UDI | U | Active |
| Hydrelix | HDX001 | FDA UDI | U | Active |
| Elasto-Gel | DR8000 | FDA UDI | U | Active |
| Hydrelix | HDX005 | FDA UDI | U | Active |
| Stimulen | ST9515 | FDA UDI | U | Active |
| Elasto-Gel | DR8200 | FDA UDI | U | Active |
| Elasto-Gel Cast & Splint Pads | K872488 | FDA 510(k) | Class I | Active |
| Elasto-Gel Occlusive Dressing | K872165 | FDA 510(k) | U | Active |
| Stimulen Collagen | K030774 | FDA 510(k) | U | Active |
| Elasto-Gel Manuka Honey Wound Dressing | K083334 | FDA 510(k) | U | Active |
| Otc Elasto-Gel Manuka Honey Wound Dressing | K102478 | FDA 510(k) | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 28, 2021 | Z-2109-2021 | — | open, classified | Dose audit failure after sterilization process |
| Nov 18, 2019 | Z-0687-2020 | — | terminated | Elasto-Gel Wound Dressing may be contaminated with mold. |
| Dec 28, 2017 | Z-1600-2018 | — | open, classified | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. |
| Dec 28, 2017 | Z-1601-2018 | — | open, classified | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. |
| Dec 28, 2017 | Z-1602-2018 | — | open, classified | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts. |
| Mar 27, 2006 | Z-0841-06 | — | terminated | The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit. |