510k
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338
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1073
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272
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822
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149
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636
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1334
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768
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100
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72
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1
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367
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589
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247
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155
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2062
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40
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311
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1591
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132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
161
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
137
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Guangzhou Wondfo Biotech Co., Ltd.
Medical Device Manufacturer
·
US , Yardley , PA
Guangzhou Wondfo Biotech Co., Ltd. - FDA 510(k) Cleared Devices
43 submissions
·
43 cleared
·
Since 2005
43
Total
43
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangzhou Wondfo Biotech Co., Ltd.
Hematology
✕
1
devices
1-1 of 1
Filters
Cleared
May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333
·
KHE
Hematology
·
265d
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43
Toxicology
24
Chemistry
15
Microbiology
3
Hematology
1