510k
Database
Specialties
Anesthesiology
207
Cardiovascular
743
Chemistry
187
Dental
472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
783
General Hospital
479
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
277
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309
Obstetrics & Gynecology
121
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81
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1483
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26
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155
Radiology
1102
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95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
97
MBI
Fastener, Fixation,...
93
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Runbio Biotech Co.,Ltd
Medical Device Manufacturer
·
US , Tacoma , WA
Runbio Biotech Co.,Ltd - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Runbio Biotech Co.,Ltd
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 22, 2019
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use...
K181551
·
LCX
Chemistry
·
254d
Cleared
Mar 28, 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627
·
LCX
Chemistry
·
208d
Cleared
Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236
·
LCX
Chemistry
·
242d
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3
Chemistry
3