Data / Medical devices / United States / Southwest Technologies, Inc.
Southwest Technologies, Inc.: FDA-registered device maker in North Kansas City, MO, United States, 2 510(k) clearances
Southwest Technologies, Inc. is registered with the FDA (registration 1929833) in North Kansas City, MO, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 9, 2004. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1929833
- Address
- 1746 Levee RD., North Kansas City, MO, United States, 64116
- Owner or operator
- SOUTHWEST TECHNOLOGIES, INC. (1929833)
- Roles
- Manufacturer
- First device listed
- July 6, 1992
- Registered through
- 2026
- Brand names listed
- AWC Biocol Wound Dressing, Cramer Blister Derm Anti-Friction Pads, Cramer Ortho Gel Athletic Padding Material, CranioCradle, Crutch Mate, Elasto-Gel Cast & Splint Padding, Elasto-Gel EP Padding, Elasto-Gel Hand Exerciser and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 9, 2004 | K030774 | STIMULEN COLLAGEN | KGN | Substantially Equivalent | Southwest Technologies, Inc. | accessdata.fda.gov |
| June 26, 1987 | K872165 | ELASTO-GEL OCCLUSIVE DRESSING | FRO | Substantially Equivalent for Some Indications | Southwest Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 28, 2021 | 88163 | Class II | Ongoing | Stimulen Collagen Moisturizing Lotion, ST9555B | Dose audit failure after sterilization process | accessdata.fda.gov |
| November 18, 2019 | 84293 | Class II | Terminated | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic | Elasto-Gel Wound Dressing may be contaminated with mold. | accessdata.fda.gov |
| December 28, 2017 | 78877 | Class II | Ongoing | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elas | 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. | accessdata.fda.gov |
| March 27, 2006 | 35051 | Not yet classified | Terminated | Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate bo | The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit. | accessdata.fda.gov |
Compare with other makers
- All makers of Nursing Pad, Cohesive Gel
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Tips And Pads, Cane, Crutch And Walker
- All makers of Exerciser, Non-Measuring
- All makers of Pack, Hot Or Cold, Reusable
Updated August 9, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.