510k
Database
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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
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
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System, Imaging, Pulsed Doppler,...
299
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Nuvaira, Inc.
Medical Device Manufacturer
·
US , Maple Grove, , MN
Nuvaira, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2024
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nuvaira, Inc.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 27, 2024
EsoCool Thermal Regulation Catheter
K233357
·
PLA
Cardiovascular
·
272d
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Cardiovascular
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