Arc Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1596-2015Class IIIThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathingFebruary 19, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K090738THERMOFLO HCH, THERMOFLO FILTERJuly 27, 2009
K063125FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)April 13, 2007
K011212FILTERFLO HDecember 20, 2001
K982239CIRCUIT GUARDAugust 14, 1998
K924997EDDMarch 28, 1995
K924627XTEND CIRCUITS (TM)April 7, 1993