510k
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Anesthesiology
337
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1073
Chemistry
271
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820
Ear, Nose, Throat
149
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634
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1332
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767
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100
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72
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1
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366
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587
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246
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155
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2061
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40
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311
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1589
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132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
207
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
160
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
136
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Quidel Corporation
Medical Device Manufacturer
·
US , San Diego , CA
Quidel Corporation - FDA 510(k) Cleared Devices
37 submissions
·
35 cleared
·
Since 2010
37
Total
35
Cleared
2
Denied
FDA 510(k) Regulatory Record - Quidel Corporation
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 25, 2010
RAPIDVUE HCG TEST
K102175
·
JHI
Chemistry
·
23d
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37
Microbiology
36
Chemistry
1