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542
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Ear, Nose, Throat
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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2923
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515
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2442
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155
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Polymer Patient Examination Glove
409
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388
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358
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Powered Laser Surgical Instrument
356
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305
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System, Imaging, Pulsed Doppler,...
299
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Automated Radiological Image...
276
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Plate, Fixation, Bone
275
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Orthopedic Stereotaxic Instrument
227
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Intervertebral Fusion Device...
220
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Auris Health, Inc., A Johnson and Johnson Family Company
Medical Device Manufacturer
·
US , Redwood , CA
Auris Health, Inc., A Johnson and Johnson Family Company - FDA 510(k)...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Auris Health, Inc., A Johnson and Johnson Family Company
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 28, 2023
Monarch Bronchoscope
K231473
·
QNW
Ear, Nose, Throat
·
190d
Cleared
Mar 11, 2021
Monarch Bronchoscope
K203614
·
QNW
Ear, Nose, Throat
·
91d
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Ear, Nose, Throat
2