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Nexera Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
4
Compliance Actions
2

Recent 510(k) Clearances

K-NumberDeviceDate
K150729SpectraShield 9500 Surgical N95 RespiratorDecember 29, 2015
K120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORJuly 5, 2012
K090414SPECTRASHIELD 9500 SURGICAL MASKFebruary 24, 2011