510k
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1613
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356
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1304
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235
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930
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2136
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1991
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126
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91
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449
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429
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272
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2705
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52
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515
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2353
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155
Categories
LZA
Polymer Patient Examination Glove
403
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System, Image Processing,...
373
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357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
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Automated Radiological Image...
275
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System, Imaging, Pulsed Doppler,...
271
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Plate, Fixation, Bone
263
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Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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American Medical Endoscopy, Inc.
Medical Device Manufacturer
·
US , Doral , FL
American Medical Endoscopy, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Medical Endoscopy, Inc.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 01, 2025
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope,...
K251652
·
FAJ
Obstetrics & Gynecology
·
64d
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2
Gastroenterology & Urology
1
Obstetrics & Gynecology
1