Top Calibre Sdn Bhd is one of 82 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Top Calibre Sdn Bhd - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Top Calibre Sdn Bhd has 5 FDA 510(k) cleared medical devices. Based in Shah Alam, MY.
Historical record: 5 cleared submissions from 2012 to 2014. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Top Calibre Sdn Bhd Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Top Calibre Sdn Bhd
5 devices
Cleared
Apr 08, 2014
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE...
General Hospital
106d
Cleared
Mar 05, 2013
MULTIPLE NAME
General Hospital
83d
Cleared
May 14, 2012
LATEX EXAMINATION GLOVES (POWDER FREE)
General Hospital
68d
Cleared
May 08, 2012
LATEX EXAMINATION GLOVES (POWDERED)
General Hospital
62d
Cleared
Jan 18, 2012
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
General Hospital
133d