510k
Database
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Anesthesiology
430
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1306
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327
Dental
1008
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190
Gastroenterology & Urology
782
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1699
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1106
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117
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83
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7
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412
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734
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321
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199
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2367
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44
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393
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1901
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141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
240
HRS
Plate, Fixation, Bone
232
IYN
System, Imaging, Pulsed Doppler,...
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
171
NKB
Thoracolumbosacral Pedicle Screw...
161
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Bionet Company, Ltd.
Medical Device Manufacturer
·
KR , Seoul
Bionet Company, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionet Company, Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 14, 2002
CARDIOTOUCH-3000
K023034
·
LOS
Cardiovascular
·
63d
Cleared
Nov 21, 2001
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
K011328
·
LOS
Cardiovascular
·
204d
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Cardiovascular
2
Radiology
1