510k
Database
Specialties
Anesthesiology
144
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584
Chemistry
167
Dental
328
Ear, Nose, Throat
68
Gastroenterology & Urology
297
General & Plastic Surgery
543
General Hospital
387
Hematology
67
Immunology
58
Medical Genetics
0
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236
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175
Obstetrics & Gynecology
70
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53
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1308
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19
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91
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890
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Bioserenity
Medical Device Manufacturer
·
FR , Paris
Bioserenity - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Bioserenity
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644
·
GWQ
Neurology
·
37d
Cleared
Dec 26, 2017
NEURONAUTE
K170138
·
GWQ
Neurology
·
343d
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2
Neurology
2