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510k Database
Manufacturers
US
Bionomy, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Bionomy, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1981
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionomy, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 31, 1983
EMBOLECTOMY CATHETER
K832023
·
DXE
Cardiovascular
·
79d
Cleared
Nov 16, 1981
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
K812111
·
DYG
Cardiovascular
·
112d
Cleared
Jun 30, 1981
OCCLUSION CATHETER
K811276
·
DYG
Cardiovascular
·
53d
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5
Cardiovascular
3
General Hospital
1
General & Plastic Surgery
1