510k
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723
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454
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86
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752
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75
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273
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System, Imaging, Pulsed Doppler,...
164
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150
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129
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122
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System, Image Processing,...
122
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Automated Radiological Image...
108
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Electrosurgical, Cutting &...
104
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Abutment, Implant, Dental,...
104
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Intervertebral Fusion Device...
96
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Fastener, Fixation,...
93
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Zephyr Sleep Technologies
Medical Device Manufacturer
·
CA , Calgary
Zephyr Sleep Technologies - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2017
5
Total
4
Cleared
1
Denied
FDA 510(k) cleared devices by Zephyr Sleep Technologies
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 24, 2020
MATRx plus
K200695
·
MNR
Dental
·
160d
Cleared
Oct 29, 2019
MATRx Plus
K191925
·
MNR
Dental
·
103d
Not Cleared
Aug 23, 2018
MATRx plus
DEN170090
·
QCJ
Dental
·
245d
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5
Dental
3
Anesthesiology
2