510k
Database
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Anesthesiology
553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
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Powered Laser Surgical Instrument
366
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Mask, Surgical
361
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Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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Sectra AB
Medical Device Manufacturer
·
US , Aubrey , TX
Sectra AB - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2000
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sectra AB
Pathology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 16, 2024
Sectra Digital Pathology Module (Version 3.3)
K232208
·
PSY
Pathology
·
265d
Cleared
Mar 31, 2020
Sectra Digital Pathology Module
K193054
·
QKQ
Pathology
·
151d
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5
Radiology
3
Pathology
2