510k
Database
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Anesthesiology
433
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1312
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327
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1010
Ear, Nose, Throat
191
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782
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1708
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1113
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117
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83
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7
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413
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735
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323
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199
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2374
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44
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393
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1906
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141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
242
IYN
System, Imaging, Pulsed Doppler,...
233
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
164
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Bio Medi Com
Medical Device Manufacturer
·
US , Indianpolis , IN
Bio Medi Com - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio Medi Com
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 20, 2002
SONOREAL 3D
K023473
·
IYO
Radiology
·
35d
Cleared
Mar 04, 2002
SONOREAL 3D SYSTEM
K020068
·
IYO
Radiology
·
54d
Cleared
Sep 26, 2001
SONOREAL 3D
K012084
·
IYO
Radiology
·
85d
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3
Radiology
3