Southwest Technologies, Inc.
Medical device manufacturer in Kansas City, MO.
5510(k) clearances
0PMA approvals
5recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102478 | OTC Elasto-Gel Manuka Honey Wound DressingFRO · Traditional | 11/03/2010SE |
| K083334 | Elasto-Gel Manuka Honey Wound DressingFRO · Traditional | 07/30/2009SE |
| K030774 | Stimulen CollagenKGN · Traditional | 08/09/2004SE |
| K872488 | Elasto-Gel Cast & Splint PadsIPM · Traditional | 09/21/1987SN |
| K872165 | Elasto-Gel Occlusive DressingFRO · Traditional | 06/26/1987SN |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2109-2021 Class II | Stimulen Collagen Moisturizing Lotion, ST9555BDose audit failure after sterilization process | 05/28/2021Open, Classified |
| Z-0687-2020 Class II | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC…Elasto-Gel Wound Dressing may be contaminated with mold. | 11/18/2019Terminated |
| Z-1602-2018 Class II | HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a)…Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during… | 12/28/2017Open, Classified |
| Z-1601-2018 Class II | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a)…Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during… | 12/28/2017Open, Classified |
| Z-1600-2018 Class II | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a)…Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during… | 12/28/2017Open, Classified |