510k
Database
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Anesthesiology
553
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1732
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386
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1404
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258
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997
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2244
General Hospital
2103
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127
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104
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8
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474
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986
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450
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286
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3083
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52
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517
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2515
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156
Categories
LZA
Polymer Patient Examination Glove
422
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
366
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Mask, Surgical
361
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Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
235
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Wavi Co.
Medical Device Manufacturer
·
US , Englewood , CO
Wavi Co. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wavi Co.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
May 06, 2022
WAVi SCAN EEG System and Accessories
K213900
·
GWQ
Neurology
·
143d
Cleared
Apr 28, 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
K162460
·
GXY
Neurology
·
238d
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Neurology
2