BSN Medical Inc

FDA Regulatory Profile

BSN Medical Inc appears in FDA public data with 1 recall, 3 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1228-2022, Class II) was initiated on February 1, 2022. Its most recent 510(k) clearance was granted on January 26, 2015.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
5
Compliance Actions
0

Known Names

bsn medical, bsn medical gmbh and co kg, bsn medical sa

Recent Recalls

NumberClassProductDate
Z-1228-2022Class II(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastiFebruary 1, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, CutimedJanuary 26, 2015
K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)July 10, 2013
K123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSDecember 18, 2012