510k
Database
Specialties
Anesthesiology
549
Cardiovascular
1720
Chemistry
385
Dental
1373
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2218
General Hospital
2088
Hematology
127
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101
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8
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474
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980
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441
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283
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3046
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52
Physical Medicine
515
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2494
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
308
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Ensodata, Inc.
Medical Device Manufacturer
·
US , Madison , WI
Ensodata, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ensodata, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 16, 2021
EnsoSleep
K210034
·
OLZ
Neurology
·
161d
Cleared
Mar 31, 2017
EnsoSleep
K162627
·
OLZ
Neurology
·
192d
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2
Neurology
2