510k
Database
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421
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1275
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311
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966
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182
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752
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1637
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1035
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114
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80
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6
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405
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706
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315
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191
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2312
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43
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381
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1853
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138
Categories
GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
258
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Automated Radiological Image...
242
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Electrosurgical, Cutting &...
227
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Plate, Fixation, Bone
227
IYN
System, Imaging, Pulsed Doppler,...
227
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
175
LZA
Polymer Patient Examination Glove
158
NKB
Thoracolumbosacral Pedicle Screw...
157
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Array Corp.
Medical Device Manufacturer
·
JP , Shibuya-Ku, Tokyo
Array Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1998
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Array Corp.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 21, 2006
FILM DIGITZER, MODEL 2908 MAMMO PRO
K063424
·
LMA
Radiology
·
38d
Cleared
Dec 17, 2003
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637
·
LMA
Radiology
·
28d
Cleared
Oct 15, 1998
FILM DIGITIZER MODEL 2905
K982785
·
LMA
Radiology
·
69d
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3
Radiology
3