36 results
·
48ms
·
Sources: EU EUDAMED, US FDA
Southwest Technologies Inc.
Manufacturer
🇺🇸 United States
SOUTHWEST TECHNOLOGIES, INC.
FDA registration
SOUTHWEST TECHNOLOGIES, INC.·7 products·🇺🇸 United States
Elasto-Gel
FDA UDI
Southwest Technologies, Inc.·00745713580004·4" x 4" Sterile Wound Dressing
BioCol
FDA UDI
Southwest Technologies, Inc.·00745713186022·5 gram Collagen Powder
Hydrelix
FDA UDI
Southwest Technologies, Inc.·00745713000021·1 gram Collagen Powder
Elasto-Gel
FDA UDI
Southwest Technologies, Inc.·00745713082003·2" x 3" Sterile Wound Dressing
Stimulen
FDA UDI
Southwest Technologies, Inc.·00745713695159·10 gram Collagen Powder
BioCol
FDA UDI
Southwest Technologies, Inc.·00745713186015·1 gram Collagen Powder
Hydrelix
FDA UDI
Southwest Technologies, Inc.·00745713000038·5 gram Collagen Powder
Stimulen
FDA UDI
Southwest Technologies, Inc.·00745713695012·1 gram Collagen Powder
Elasto-Gel
FDA UDI
Southwest Technologies, Inc.·00745713586006·6" x 8" Sterile Wound Dressing
ELASTOGEL HYPOTHERMIA MITTS
FDA Adverse Event
Injury
·SOUTHWEST TECHNOLOGIES, INC.·Product code IME·October 22, 2018
ELASTOGEL HYPOTHERMIA MITTS & SLIPPERS
FDA Adverse Event
Injury
·SOUTHWEST TECHNOLOGIES INC.·Product code IME·October 22, 2018
*
FDA Adverse Event
Malfunction
·SOUTHWEST TECHNOLOGIES, INC·Product code IMD·September 20, 2009
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-Gel(TM), SL3008
FDA Recall
Open, Classified
·Southwest Technologies Inc·Product code N/A·December 28, 2017
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) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
FDA Recall
Open, Classified
·Southwest Technologies Inc·Product code N/A·December 28, 2017
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-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012
FDA Recall
Open, Classified
·Southwest Technologies Inc·Product code N/A·December 28, 2017
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-Gel(TM), SL3008
FDA Enforcement
Class II
·Ongoing·Southwest Technologies Inc·May 9, 2018
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 boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
FDA Recall
Terminated
·Southwest Technologies Inc·Product code FRO·March 27, 2006
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-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012
FDA Enforcement
Class II
·Ongoing·Southwest Technologies Inc·May 9, 2018