510k
Database
Specialties
Anesthesiology
542
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1680
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365
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1337
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248
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972
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2194
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2047
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126
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99
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8
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469
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965
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433
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275
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2923
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52
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515
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2442
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Mycardium AI Limited
Medical Device Manufacturer
·
GB , Liverpool
Mycardium AI Limited - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mycardium AI Limited
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 30, 2025
EchoConfidence (USA)
K250670
·
QIH
Radiology
·
117d
Cleared
Nov 15, 2024
1CMR Pro
K242062
·
LLZ
Radiology
·
123d
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2
Radiology
2