510k
Database
Specialties
Anesthesiology
134
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569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
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168
Obstetrics & Gynecology
61
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49
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1295
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18
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86
Radiology
870
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Fona S.R.L
Medical Device Manufacturer
·
IT , Assago
Fona S.R.L - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Fona S.R.L
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 23, 2022
FONA XDC
K222274
·
EHD
Radiology
·
25d
Cleared
Mar 02, 2022
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K213579
·
OAS
Radiology
·
112d
Cleared
Aug 30, 2021
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
K212103
·
MUH
Radiology
·
55d
Cleared
Nov 03, 2016
FONA Pan/Ceph
K161131
·
MUH
Radiology
·
196d
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4
Radiology
4