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3571
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435
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System, Image Processing,...
705
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591
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519
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518
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
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Intervertebral Fusion Device...
403
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391
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Thoracolumbosacral Pedicle Screw...
347
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Prosthesis, Knee,...
346
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Manufacturers
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Manufacturers
US
Obs Medical
Medical Device Manufacturer
·
US , Carmel , IN
Obs Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2007
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Obs Medical
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 15, 2011
VISENSIA, VISENSIA WITH ALERT
K110953
·
MHX
Cardiovascular
·
71d
Cleared
Jul 17, 2008
VISENSIA
K081140
·
MHX
Cardiovascular
·
86d
Cleared
Aug 31, 2007
BIOSIGN CENTRAL STATION
K071606
·
MWI
Cardiovascular
·
80d
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3
Cardiovascular
3