510k
Database
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Anesthesiology
538
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1656
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360
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1323
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244
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957
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2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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First Light Diagnostics, Inc.
Medical Device Manufacturer
·
US , Chelmsford , MA
First Light Diagnostics, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - First Light Diagnostics, Inc.
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545
·
QUU
Microbiology
·
90d
Cleared
Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490
·
LLH
Microbiology
·
569d
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2
Microbiology
2