510k
Database
Specialties
Anesthesiology
399
Cardiovascular
1209
Chemistry
302
Dental
909
Ear, Nose, Throat
173
Gastroenterology & Urology
714
General & Plastic Surgery
1543
General Hospital
930
Hematology
112
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79
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3
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395
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671
Obstetrics & Gynecology
292
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178
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2201
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42
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360
Radiology
1778
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
LLZ
System, Image Processing,...
238
QIH
Automated Radiological Image...
232
IYN
System, Imaging, Pulsed Doppler,...
221
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Hung Chun Bio-S Co., Ltd.
Medical Device Manufacturer
·
TW , New Taipei City
Hung Chun Bio-S Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hung Chun Bio-S Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 11, 2018
Ti-one 101 TS Dental Implant System
K172821
·
DZE
Dental
·
266d
Cleared
Jul 27, 2012
HC-BIOS DENTAL IMPLANT
K110425
·
DZE
Dental
·
529d
Filters
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3
Dental
2
Orthopedic
1