510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
162
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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