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1208
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4660
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3346
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2794
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472
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2457
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4191
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3860
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808
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796
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15
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1914
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1777
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890
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497
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7959
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167
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963
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4789
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1242
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730
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696
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570
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
418
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Screw, Fixation, Bone
402
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Manufacturers
US
Oktas
Medical Device Manufacturer
·
US , Ashland , MA
Oktas - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1994
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oktas
Gastroenterology & Urology
✕
2
devices
1-2 of 2
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Cleared
Nov 30, 1994
OKTAS STEREO VIEWING SYSTEM
K944254
·
FET
Gastroenterology & Urology
·
91d
Cleared
Jun 17, 1994
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
K941919
·
FET
Gastroenterology & Urology
·
58d
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7
General & Plastic Surgery
4
Gastroenterology & Urology
2
Dental
1