510k
Database
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Anesthesiology
1011
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4225
Chemistry
3201
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2735
Ear, Nose, Throat
462
Gastroenterology & Urology
2285
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3842
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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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7239
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163
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958
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4595
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1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
671
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Electrosurgical, Cutting &...
535
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
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
29
devices
26-29 of 29
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1
2
Cleared
Nov 18, 2014
3MP Color LCD monitor, RadiForce RS340
K143098
·
PGY
Radiology
·
21d
Cleared
Apr 04, 2014
8MP COLOR LCD MONITOR, RADIFORCE RX850
K140702
·
PGY
Radiology
·
15d
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