510k
Database
Specialties
Anesthesiology
553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
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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
238
MAX
Intervertebral Fusion Device...
235
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Eneura, Inc.
Medical Device Manufacturer
·
US , Sunnyvale , CA
Eneura, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eneura, Inc.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
May 16, 2023
SAVI Dual (TM) Migraine Therapy
K230358
·
OKP
Neurology
·
95d
Cleared
Feb 25, 2019
SpringTMS
K182976
·
OKP
Neurology
·
122d
Cleared
Jun 26, 2017
SpringTMS
K162797
·
OKP
Neurology
·
265d
Cleared
Aug 23, 2016
sTMS mini
K161663
·
OKP
Neurology
·
68d
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4
Neurology
4