510k
Database
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Anesthesiology
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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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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GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
207
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System, Imaging, Pulsed Doppler,...
205
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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
MAX
Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
132
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Intelligent Medical Devices, Inc.
Medical Device Manufacturer
·
US , Beverly , MA
Intelligent Medical Devices, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2013
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intelligent Medical Devices, Inc.
Microbiology
✕
4
devices
1-4 of 4
Filters
Cleared
May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198
·
OQO
Microbiology
·
106d
Cleared
Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235
·
OZN
Microbiology
·
85d
Cleared
Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584
·
OCC
Microbiology
·
82d
Cleared
Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753
·
NIJ
Microbiology
·
223d
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4
Microbiology
4