510k
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634
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1930
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414
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1572
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277
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1095
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2466
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2279
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142
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110
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510
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1097
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509
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330
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3340
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57
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556
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2756
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165
Categories
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System, Image Processing,...
451
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Polymer Patient Examination Glove
434
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Powered Laser Surgical Instrument
403
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384
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Electrosurgical, Cutting &...
356
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System, Imaging, Pulsed Doppler,...
323
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Plate, Fixation, Bone
316
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Automated Radiological Image...
284
MAX
Intervertebral Fusion Device...
254
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Orthopedic Stereotaxic Instrument
252
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Manufacturers
US
Suzuken Co., Ltd.
Medical Device Manufacturer
·
US , Walker , MI
Suzuken Co., Ltd. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1981
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzuken Co., Ltd.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 26, 1982
KENZ-GELECT GEL PAD
K820991
·
GYB
Neurology
·
18d
Cleared
Nov 02, 1981
KENZ-GELECT
K812263
·
GYB
Neurology
·
81d
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13
Cardiovascular
11
Neurology
2