510k
Database
Specialties
Anesthesiology
136
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571
Chemistry
165
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319
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
526
General Hospital
378
Hematology
67
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57
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0
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234
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173
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62
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51
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1296
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18
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88
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876
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
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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Terragene
Medical Device Manufacturer
·
AR , Alvear
Terragene - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Terragene
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Aug 04, 2025
Terragene® Bionova® BT20 Biological Indicator
K251122
·
FRC
General Hospital
·
115d
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1
General Hospital
1