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4849
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3434
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474
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2510
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3889
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497
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8079
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176
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978
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5128
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757
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696
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System, Imaging, Pulsed Doppler,...
579
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570
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
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Intervertebral Fusion Device...
436
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Screw, Fixation, Bone
403
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Manufacturers
US
Olympus America, Inc.
Medical Device Manufacturer
·
US , Lake Success , NY
Olympus America, Inc. - FDA 510(k) Cleared Devices
149 submissions
·
149 cleared
·
Since 1994
149
Total
149
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus America, Inc.
✕
1
devices
1-1 of 1
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Cleared
Nov 18, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K973128
·
FOG
Anesthesiology
·
89d
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149
Gastroenterology & Urology
36
Chemistry
34
Immunology
19
Radiology
15
General & Plastic Surgery
14
Ear, Nose, Throat
13
Obstetrics & Gynecology
12
Orthopedic
2
General Hospital
1
Toxicology
1