510k
Database
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Anesthesiology
542
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1685
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370
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1345
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250
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979
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2202
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2052
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126
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100
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8
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472
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975
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436
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279
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2970
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52
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515
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2458
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155
Categories
LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
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Dimensional Bioceramics, LLC
Medical Device Manufacturer
·
US , Scotts Valley , CA
Dimensional Bioceramics, LLC - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dimensional Bioceramics, LLC
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 20, 2019
DB-CMF
K182742
·
GXP
Neurology
·
265d
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5
Orthopedic
4
Neurology
1