510k
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327
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1055
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267
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791
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147
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617
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1300
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741
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97
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72
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1
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364
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556
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240
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154
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2022
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38
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308
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1561
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129
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Powered Laser Surgical Instrument
227
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207
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System, Imaging, Pulsed Doppler,...
205
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Automated Radiological Image...
203
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System, Image Processing,...
196
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
167
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Abutment, Implant, Dental,...
153
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Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
132
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Applied Imaging Corp.
Medical Device Manufacturer
·
US , Santa Clara , CA
Applied Imaging Corp. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1990
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Applied Imaging Corp.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 10, 2005
CYTOVISION FOR CEP XY
K042542
·
NTH
Hematology
·
112d
Cleared
Aug 30, 2000
SLIDESCAN
K001420
·
JOY
Hematology
·
117d
Cleared
Jun 09, 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375
·
JOY
Hematology
·
130d
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7
Pathology
4
Hematology
3