510k
Database
Specialties
Anesthesiology
540
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1663
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362
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1334
Ear, Nose, Throat
244
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963
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2184
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2043
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126
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97
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8
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466
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963
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433
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274
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2875
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52
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515
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2430
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Iterative Health
Medical Device Manufacturer
·
US , Cambridge , MA
Iterative Health - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iterative Health
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 22, 2025
SKOUT system
K253664
·
QNP
Gastroenterology & Urology
·
32d
Cleared
May 09, 2025
SKOUT system
K251126
·
QNP
Gastroenterology & Urology
·
28d
Filters
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2
Gastroenterology & Urology
2