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510k Database
Manufacturers
US
Or-Nim Medical , Ltd.
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Medical Device Manufacturer
·
US , Washington , DC
Or-Nim Medical , Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2008
Recent clearances:
CerOX
,
CEROX
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Or-Nim Medical , Ltd.
Cardiovascular
✕
5
devices
1-5 of 5
Filters
Cleared
Nov 06, 2015
CerOX
K150268
·
DPW
Cardiovascular
·
275d
Cleared
Sep 13, 2013
CEROX
K131854
·
DPW
Cardiovascular
·
84d
Cleared
Jan 25, 2011
CEROX, MODEL 321OF
K100875
·
MUD
Cardiovascular
·
301d
Cleared
Jan 19, 2010
CEROX MODEL 3210
K093923
·
MUD
Cardiovascular
·
28d
Cleared
Feb 28, 2008
PACIFICA
K073407
·
MUD
Cardiovascular
·
86d
Filters
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5
Cardiovascular
5