510k
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117
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507
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156
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276
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59
Gastroenterology & Urology
258
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439
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339
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63
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55
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221
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133
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43
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41
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1214
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18
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58
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789
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86
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IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
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System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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GIE Medical
Medical Device Manufacturer
·
US , Brooklyn Park , MN
GIE Medical - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by GIE Medical
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 13, 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987
·
FGE
Gastroenterology & Urology
·
91d
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1
Gastroenterology & Urology
1