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Baxano, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K113073IO-TOME DEVICEJuly 27, 2012
K113533NEURO CHECK DEVICE WITH IO-FLEX WIREApril 11, 2012
K110696NEURO CHECK DEVICE WITH IO-FLEX WIREJuly 7, 2011
K102594IO-FLEX CATHETERJanuary 19, 2011
K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESJuly 23, 2010
K092729BAXANO NEURO CHECK DEVICEOctober 2, 2009
K081742BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25September 17, 2008
K080494BAXANO ULTRA LOW PROFILE RONGEURMarch 4, 2008
K063231MICROBLADE SHAVER AND ACCESSORIESApril 16, 2007
K062711ULTRA LOW PROFILE RONGEURMarch 7, 2007