Galemed Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K132679AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERApril 18, 2014
K133957DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEApril 14, 2014
K122627GIO DIGITAL PRESSURE GUAGESAugust 22, 2013
K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEOctober 15, 2008
K072755GALEMED CPAP MASKNovember 16, 2007
K022124GALEMED PEAK FLOW METER, MODELS 3751/3752April 3, 2003
K021742GALEMED NEB-EASY NEBULIZEROctober 25, 2002