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204
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739
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187
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468
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91
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397
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776
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476
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77
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64
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277
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302
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117
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79
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1477
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26
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153
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1094
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94
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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131
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126
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125
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Automated Radiological Image...
112
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
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Intervertebral Fusion Device...
96
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Thoracolumbosacral Pedicle Screw...
93
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Oventus Manufacturing Pty, Ltd.
Medical Device Manufacturer
·
AU , Brisbane
Oventus Manufacturing Pty, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Oventus Manufacturing Pty, Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 29, 2019
O2Vent Optima
K190236
·
LRK
Dental
·
204d
Cleared
Jul 11, 2017
O2Vent W
K171316
·
LRK
Dental
·
68d
Cleared
Sep 23, 2016
O2VENT T
K161832
·
LRK
Dental
·
80d
Cleared
Mar 17, 2016
OVENT
K160234
·
LRK
Dental
·
45d
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4
Dental
4