Medical Device Manufacturer · US , Norcross , GA

Regent Medical Americas, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2005

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Regent Medical Americas, LLC General Hospital ✕

7 devices

1-7 of 7

Cleared Apr 10, 2006

BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE

General Hospital · 122d

Cleared Mar 10, 2006

BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE

General Hospital · 126d

Cleared Mar 07, 2006

BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

General Hospital · 88d

Cleared Feb 01, 2006

BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE

General Hospital · 54d

Cleared Aug 12, 2005

BIOGEL LATEX STERILE POWDER-FREE GLOVE

General Hospital · 123d

Cleared Apr 26, 2005

ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE

General Hospital · 55d

Cleared Mar 16, 2005

BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE

General Hospital · 48d