510k
Database
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Anesthesiology
204
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734
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187
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459
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89
Gastroenterology & Urology
390
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766
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472
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77
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62
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1
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274
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295
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114
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76
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1473
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26
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152
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1081
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93
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IYN
System, Imaging, Pulsed Doppler,...
166
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Apriomed AB
Medical Device Manufacturer
·
SE , Uppsala
Apriomed AB - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Apriomed AB
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 18, 2018
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756
·
FCG
Gastroenterology & Urology
·
169d
Cleared
Jun 09, 2015
Morrison Steerable Needle
K150625
·
KNW
Gastroenterology & Urology
·
90d
Filters
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3
Gastroenterology & Urology
2
General & Plastic Surgery
1