510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2838
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
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.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 07, 2017
Insulia Diabetes Management Companion
K172177
·
NDC
General Hospital
·
111d
Cleared
Jun 19, 2017
Insulia Diabetes Management Companion
K170669
·
NDC
General Hospital
·
105d
Cleared
Nov 09, 2016
Insulia Diabetes Management Companion
K161433
·
NDC
General Hospital
·
169d
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5
General Hospital
3
Chemistry
2