510k
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1317
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4784
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3357
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2802
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474
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2459
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4192
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3873
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822
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796
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15
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1914
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1836
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893
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497
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8079
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167
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965
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5125
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1242
Categories
LLZ
System, Image Processing,...
757
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
579
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Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
HWC
Screw, Fixation, Bone
403
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Manufacturers
US
Softek Ent.
Medical Device Manufacturer
·
US , Englewood , CO
Softek Ent. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1997
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Softek Ent.
Dental
✕
1
devices
1-1 of 1
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Cleared
Oct 14, 1997
TONGUE KLEAN
K973175
·
LCN
Dental
·
50d
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Dental
1