510k
Database
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Anesthesiology
538
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1656
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360
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1323
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244
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957
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2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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155
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LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Atmo Biosciences, Ltd.
Medical Device Manufacturer
·
AU , Box Hill
Atmo Biosciences, Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Atmo Biosciences, Ltd.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 26, 2025
Atmo Gas Capsule System
K250940
·
NYV
Gastroenterology & Urology
·
90d
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1
Gastroenterology & Urology
1