510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2900
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Bionet Co., Ltd.
Medical Device Manufacturer
·
KR , Wonju, Kwangwon-Do
Bionet Co., Ltd. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2005
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionet Co., Ltd.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 16, 2005
FC 700 FETAL MONITOR
K043597
·
HGM
Obstetrics & Gynecology
·
352d
Cleared
Dec 16, 2005
FC 1400 FETAL MONITOR
K043598
·
HGM
Obstetrics & Gynecology
·
352d
Filters
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11
Cardiovascular
7
Obstetrics & Gynecology
2
Anesthesiology
1
Radiology
1