510k
Database
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Anesthesiology
434
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1318
Chemistry
327
Dental
1015
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192
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784
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1721
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1118
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117
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83
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7
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413
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737
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324
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199
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2378
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44
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394
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1913
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141
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GEX
Powered Laser Surgical Instrument
283
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System, Image Processing,...
270
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Automated Radiological Image...
247
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Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
234
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
165
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Advanced Diagnostics, Inc.
Medical Device Manufacturer
·
US , Richland , WA
Advanced Diagnostics, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2000
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Diagnostics, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
May 10, 2002
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013886
·
NCS
Radiology
·
168d
Cleared
Nov 14, 2001
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013291
·
NCS
Radiology
·
43d
Cleared
Nov 30, 2000
OS-2000 OPTICAL SONOGRAPHY SYSTEM
K001510
·
NCS
Radiology
·
199d
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4
Radiology
3
Chemistry
1