Hartmann USA, Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1858-2012Class IIHartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 totMay 14, 2012
Z-1857-2012Class IIHartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total spongeMay 14, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K242758Atrauman® AgDecember 9, 2024