510k
Database
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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
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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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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
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LZA
Polymer Patient Examination Glove
408
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System, Image Processing,...
384
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358
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Powered Laser Surgical Instrument
353
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Electrosurgical, Cutting &...
302
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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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Gt Medical Technologies
Medical Device Manufacturer
·
US , Tempe , AZ
Gt Medical Technologies - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gt Medical Technologies
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 09, 2022
GammaTile
K221539
·
KXK
Radiology
·
166d
Cleared
Jan 23, 2020
GammaTile
K190839
·
KXK
Radiology
·
297d
Cleared
Mar 13, 2019
GammaTile
K190296
·
KXK
Radiology
·
30d
Filters
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3
Radiology
3