510k
Database
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Anesthesiology
545
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1709
Chemistry
380
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1354
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252
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982
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2215
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2078
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126
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100
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8
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474
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980
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441
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282
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3023
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52
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515
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2484
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
399
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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Otsuka America Pharmaceutical, Inc.
Medical Device Manufacturer
·
US , Rockville , MD
Otsuka America Pharmaceutical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Otsuka America Pharmaceutical, Inc.
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 30, 2024
Rejoyn
K231209
·
SAP
Neurology
·
338d
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3
Cardiovascular
2
Neurology
1