Pt Mahakarya Inti Buana is one of 38 FDA 510(k) medical device manufacturers from Indonesia in the dataset, ranked by real submission volume.
Pt Mahakarya Inti Buana - FDA 510(k) Cleared Devices
Recent clearances: SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE), BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE, SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
9
Total
9
Cleared
0
Denied
Pt Mahakarya Inti Buana has 9 FDA 510(k) cleared medical devices. Based in Morawa, Sumut, ID.
Historical record: 9 cleared submissions from 2005 to 2011. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Pt Mahakarya Inti Buana Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Pt Mahakarya Inti Buana
9 devices
Cleared
Aug 12, 2011
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN,...
General Hospital
95d
Cleared
Apr 23, 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
General Hospital
59d
Cleared
Mar 15, 2007
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
General Hospital
105d
Cleared
Nov 30, 2006
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
General Hospital
114d
Cleared
Nov 03, 2006
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
General Hospital
185d
Cleared
Jun 02, 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
General Hospital
186d
Cleared
Mar 30, 2006
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
General Hospital
115d
Cleared
Feb 13, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
General Hospital
70d
Cleared
Sep 30, 2005
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
General Hospital
39d