19 results · 27ms · Sources: EU EUDAMED, US FDA

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GEL4MED, INC.

FDA registration
GEL4MED, INC.·1 product·🇺🇸 United States

RV-X1

FDA UDI
Gel4med, Inc.·00850058790114·

Suprello

FDA UDI
Gel4med, Inc.·00850058790091·

G4Derm Plus Synthetic Wound Matrix

FDA UDI
Gel4med, Inc.·00850058790008·

G4Derm Plus

FDA UDI
Gel4med, Inc.·00850058790145·

G4Derm Plus Synthetic Wound Matrix

FDA UDI
Gel4med, Inc.·00850058790015·

G4Derm Plus

FDA UDI
Gel4med, Inc.·00850058790138·

G4Derm Plus Synthetic Wound Matrix

FDA UDI
Gel4med, Inc.·00850058790022·

Suprello

FDA UDI
Gel4med, Inc.·00850058790084·

G4Derm Plus

FDA UDI
Gel4med, Inc.·00850058790152·

RV-X1

FDA UDI
Gel4med, Inc.·00850058790121·

Suprello

FDA UDI
Gel4med, Inc.·00850058790060·

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

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

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 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 Enforcement
Class II ·Ongoing·Southwest Technologies Inc·May 9, 2018

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 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

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

FDA Enforcement
Class I ·Ongoing·Mac Medical Supply Co Inc·September 29, 2021