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538
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1656
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360
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1323
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243
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957
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2176
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2038
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126
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97
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462
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959
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433
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274
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2838
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52
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515
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2413
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155
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LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
382
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358
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Powered Laser Surgical Instrument
351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
276
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
213
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Novoxel , Ltd.
Medical Device Manufacturer
·
IL , Netanya
Novoxel , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Novoxel , Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 21, 2023
Tixel® 2 System
K223033
·
GEI
General & Plastic Surgery
·
265d
Cleared
Feb 25, 2021
Tixel System
K202988
·
GEI
General & Plastic Surgery
·
148d
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3
General & Plastic Surgery
2
Ophthalmic
1