510k
Database
Specialties
Anesthesiology
510
Cardiovascular
1585
Chemistry
355
Dental
1279
Ear, Nose, Throat
234
Gastroenterology & Urology
922
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2111
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1873
Hematology
126
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91
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8
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449
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930
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421
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267
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2681
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50
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507
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2294
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
386
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
279
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Beacon Biosignals, Inc.
Medical Device Manufacturer
·
US , Boston , MA
Beacon Biosignals, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Beacon Biosignals, Inc.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 22, 2024
Dreem 3S
K242094
·
OLZ
Neurology
·
128d
Cleared
Mar 08, 2024
SleepStageML
K233438
·
OLZ
Neurology
·
147d
Cleared
Aug 18, 2023
Dreem 3S
K223539
·
OLZ
Neurology
·
268d
Filters
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3
Neurology
3