510k
Database
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3046
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515
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2494
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LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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363
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359
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308
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
233
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Zenith Technical Innovations
Medical Device Manufacturer
·
US , Gurnee , IL
Zenith Technical Innovations - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zenith Technical Innovations
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 27, 2023
Therm-X
K231912
·
IRP
Physical Medicine
·
28d
Cleared
Feb 28, 2020
Therm-X
K193550
·
IRP
Physical Medicine
·
70d
Cleared
May 10, 2019
Therm-X
K190854
·
IRP
Physical Medicine
·
38d
Cleared
Aug 03, 2018
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
K181149
·
IRP
Physical Medicine
·
94d
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5
Physical Medicine
4
Cardiovascular
1