Company ยท US
Southwest Technologies Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2010. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 3, 2010 | K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING Southwest Technologies, Inc. | FRO |
| Jul 30, 2009 | K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING Southwest Technologies, Inc. | FRO |
| Aug 9, 2004 | K030774 | STIMULEN COLLAGEN Southwest Technologies, Inc. | KGN |
| Sep 21, 1987 | K872488 | ELASTO-GEL CAST & SPLINT PADS Southwest Technologies, Inc. | IPM |
| Jun 26, 1987 | K872165 | ELASTO-GEL OCCLUSIVE DRESSING Southwest Technologies, Inc. | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2021 | Southwest Technologies Inc Stimulen Collagen Moisturizing Lotion, ST9555B Open, Classified |
KGN | K030774 |
| Dec 13, 2019 | Southwest Technologies Inc Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic Terminated |
FRO | K872165 |
| Dec 28, 2017 | Southwest Technologies Inc HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands:
(a) Elasto-Gel(TM), SL3000
(b) Elasto-Gel(TM), SL3000LV
(c) Elasto-Gel(TM), SL3001
(d) Elasto-Gel(TM), SL3007
(e) Elasto Open, Classified |
N/A | None listed |
| Dec 28, 2017 | Southwest Technologies Inc HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands:
(a) Elasto-Gel(TM), TM7006
(b) Elasto-Gel(TM), TM7006LV
(c) Elasto-Gel(TM), TM7007
(d) Elasto-Gel(TM), TM7008
(e) Elasto-Ge Open, Classified |
N/A | None listed |
| Dec 28, 2017 | Southwest Technologies Inc 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( Open, Classified |
N/A | None listed |
| May 4, 2006 | Southwest Technologies Inc 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 bo Terminated |
FRO | K872165 |