510k
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1011
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4263
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3201
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2735
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463
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2285
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3843
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3545
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773
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774
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15
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1404
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1690
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849
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492
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7240
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163
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958
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4596
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1235
Categories
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System, Image Processing,...
725
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Plate, Fixation, Bone
671
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Electrosurgical, Cutting &...
535
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
431
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
386
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Manufacturers
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Manufacturers
JP
Eizo Corporation
Medical Device Manufacturer
·
JP , Hakusan, Ishikawa
Eizo Corporation - FDA 510(k) Cleared Devices
29 submissions
·
29 cleared
·
Since 2013
Official Website
29
Total
29
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Jan 31, 2014
6MP COLOR LCD MONITOR, RADIFORCE RX650
K134002
·
LLZ
Radiology
·
35d
Cleared
Jul 03, 2013
2MP COLOR LCD MONITOR, RADIFORCE MX215
K131090
·
LLZ
Radiology
·
76d
1
2
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29
Radiology
27
General & Plastic Surgery
1
Pathology
1