510k
Database
Specialties
Anesthesiology
130
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565
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
369
Hematology
67
Immunology
56
Medical Genetics
0
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232
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163
Obstetrics & Gynecology
60
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49
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1285
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18
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85
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866
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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,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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De G?tzen S.R.L.
Medical Device Manufacturer
·
IT , Olgiate Olona
De G?tzen S.R.L. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by De G?tzen S.R.L.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 28, 2023
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark...
K231055
·
EHD
Radiology
·
259d
Cleared
Feb 05, 2021
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy...
K203374
·
MUH
Radiology
·
81d
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Radiology
2