510k
Database
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522
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1610
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356
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1304
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235
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927
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2131
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1978
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126
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91
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8
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449
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940
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426
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271
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2697
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52
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514
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2319
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155
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Polymer Patient Examination Glove
403
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System, Image Processing,...
367
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Powered Laser Surgical Instrument
350
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Mask, Surgical
347
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Electrosurgical, Cutting &...
294
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Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
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Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Endosound, Inc.
Medical Device Manufacturer
·
US , Portland , OR
Endosound, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Endosound, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 17, 2025
Biopsy Port Adapter
K250145
·
ODC
Gastroenterology & Urology
·
269d
Cleared
Dec 27, 2023
EndoSound Vision System
K232518
·
ODG
Gastroenterology & Urology
·
131d
Filters
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Gastroenterology & Urology
2