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362
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244
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2182
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2039
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126
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97
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433
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2862
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52
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515
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2418
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155
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Polymer Patient Examination Glove
407
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382
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358
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351
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302
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System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
219
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HeartLung Corporation
Medical Device Manufacturer
·
US , Torrance , CA
HeartLung Corporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - HeartLung Corporation
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 19, 2025
AI-CVD
K252029
·
QIH
Radiology
·
172d
Cleared
Oct 10, 2024
AutoChamber
K240786
·
QIH
Radiology
·
202d
Cleared
Jul 29, 2022
ABMD Software
K213760
·
KGI
Radiology
·
240d
Filters
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3
Radiology
3