DermaCare, Inc.

FDA Regulatory Profile

DermaCare, Inc. appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (D-034-2013, Class II) was initiated on September 17, 2012. Its most recent 510(k) clearance was granted on October 24, 2006.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-034-2013Class IIUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleaSeptember 17, 2012
D-035-2013Class IIUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'meSeptember 17, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K060653THERMACLEAROctober 24, 2006
K893995DERMACARE TIE HOLDERAugust 11, 1989
K884656DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEPNovember 25, 1988