510k
Database
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Anesthesiology
540
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1666
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362
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1334
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245
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963
General & Plastic Surgery
2186
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2043
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126
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97
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8
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466
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965
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433
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274
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2886
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52
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515
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2431
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155
Categories
LZA
Polymer Patient Examination Glove
408
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System, Image Processing,...
384
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Mask, Surgical
358
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Powered Laser Surgical Instrument
353
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Neauvia North America, Inc.
Medical Device Manufacturer
·
US , Raliegh , NC
Neauvia North America, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neauvia North America, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 17, 2023
Plasma IQ
K223222
·
GEI
General & Plastic Surgery
·
92d
Cleared
Dec 09, 2021
Plasma IQ
K212329
·
GEI
General & Plastic Surgery
·
135d
Cleared
Mar 06, 2020
Plasma IQ
K192813
·
GEI
General & Plastic Surgery
·
157d
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3
General & Plastic Surgery
3