510k
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538
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1654
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360
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1323
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243
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957
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2175
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2038
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126
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97
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462
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958
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433
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274
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2828
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52
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515
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2403
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155
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LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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X6 Innovations
Medical Device Manufacturer
·
FR , Paris
X6 Innovations - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - X6 Innovations
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 20, 2023
Perifit Care+
K231780
·
HIR
Gastroenterology & Urology
·
187d
Cleared
Feb 10, 2023
Perifit
K221476
·
HIR
Gastroenterology & Urology
·
266d
Filters
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3
Gastroenterology & Urology
2
Obstetrics & Gynecology
1