510k
Database
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Anesthesiology
541
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1672
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364
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1336
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245
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969
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2190
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2046
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126
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97
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8
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466
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965
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433
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274
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2912
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52
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515
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2433
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155
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LZA
Polymer Patient Examination Glove
408
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System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Elidah, Inc.
Medical Device Manufacturer
·
US , Monroe , CT
Elidah, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elidah, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
CT
Jan 23, 2026
Elitone for Men
K253285
·
QAJ
Gastroenterology & Urology
·
116d
Cleared
CT
Feb 24, 2023
ELITONE Urge Urinary Incontinence Device
K223884
·
QAJ
Gastroenterology & Urology
·
59d
Cleared
Feb 11, 2019
Elitone Device
K183585
·
QAJ
Gastroenterology & Urology
·
52d
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3
Gastroenterology & Urology
3