510k
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Anesthesiology
134
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569
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165
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316
Ear, Nose, Throat
68
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289
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522
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373
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67
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56
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0
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233
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169
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62
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49
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1295
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18
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87
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871
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Zymo Research
Medical Device Manufacturer
·
US , Irvine , CA
Zymo Research - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Zymo Research
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013
·
QBD
Microbiology
·
171d
Cleared
Dec 14, 2020
DNA/RNA Shield Collection Tube
K202641
·
QBD
Microbiology
·
94d
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2
Microbiology
2