510k
Database
Specialties
Anesthesiology
538
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1656
Chemistry
360
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1323
Ear, Nose, Throat
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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8
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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
Physical Medicine
515
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2413
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
213
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Voluntis Sa.
Medical Device Manufacturer
·
FR , Paris
Voluntis Sa. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2016
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Voluntis Sa.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 12, 2023
Insulia Bolus Companion
K232451
·
NDC
Chemistry
·
120d
Cleared
Jun 04, 2021
Insulia Diabetes Management Companion
K202596
·
NDC
Chemistry
·
269d
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5
General Hospital
3
Chemistry
2