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962
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3571
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1311
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2186
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437
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2139
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3587
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3374
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319
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292
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15
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1145
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1617
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804
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472
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81
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694
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4149
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Categories
LLZ
System, Image Processing,...
705
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Plate, Fixation, Bone
610
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Electrosurgical, Cutting &...
520
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Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
391
JWH
Prosthesis, Knee,...
350
NKB
Thoracolumbosacral Pedicle Screw...
347
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Manufacturers
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Manufacturers
US
Smartpractice
Medical Device Manufacturer
·
US , Phoenix , AZ
Smartpractice - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smartpractice
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 19, 2012
FINN CHAMBERS AQUA
K123184
·
KXF
General Hospital
·
70d
Cleared
Mar 15, 2011
ALLERGEAZE R CLEAR
K103409
·
KXF
General Hospital
·
113d
Cleared
Dec 22, 2006
ALLERGEAZE PATCH TEST CHAMBERS
K063160
·
KXF
General Hospital
·
66d
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4
General Hospital
3
Dental
1