Bright Element Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Bright Element Sdn Bhd - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Bright Element Sdn Bhd has 4 FDA 510(k) cleared medical devices. Based in Klang Selangor Darul Ehsan, MY.
Historical record: 4 cleared submissions from 2006 to 2007. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Bright Element Sdn Bhd Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bright Element Sdn Bhd
4 devices
Cleared
Mar 02, 2007
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
General Hospital
71d
Cleared
Feb 23, 2007
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
General Hospital
63d
Cleared
May 24, 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
General Hospital
37d
Cleared
May 19, 2006
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
General Hospital
32d