Beiersdorf Inc

FDA Regulatory Profile

Summary

Total Recalls
8 (5 Class I)
510(k) Clearances
48
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0010-2022Class ICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can,September 30, 2021
D-0017-2022Class IICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g)September 30, 2021
D-0011-2022Class ICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g)September 30, 2021
D-0015-2022Class IICoppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can,September 30, 2021
D-0012-2022Class ICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g)September 30, 2021
D-0016-2022Class IICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g)September 30, 2021
D-0013-2022Class ICoppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can,September 30, 2021
D-0014-2022Class ICoppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, OctoSeptember 30, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 710December 18, 2009
K032462CURAD SILVER ACTIVE GEL BANDAGEFebruary 10, 2004
K032463CURAD SILVER BANDAGEFebruary 10, 2004
K024057CURAD SCAR THERAPYJune 18, 2003
K022645CURADNovember 5, 2002
K952526CUTINOVA CAVITYAugust 14, 1995
K943363CUTIPLAST STERILMarch 15, 1995
K944581CUTINOVA THIN WOUND DRESSINGDecember 2, 1994
K935630NORTAOctober 7, 1994
K940378COVERLET ADHESIVE DRESSINGJuly 29, 1994
K925630ELASTOPLAST HEAT PLASTERFebruary 25, 1994
K926399CUTIFILM(R) FILMNovember 15, 1993
K923404LUEKOFLEX SURGICAL TAPESeptember 9, 1992
K921759ACRYLASTICAugust 10, 1992
K921760TRICOPLASTAugust 10, 1992
K905688CUTINOVA HYDROApril 1, 1991
K910274ARTIFLEX(TM)March 5, 1991
K904500ELASTOPLASTNovember 21, 1990
K896891LEUKOSILK(TM) SURGICAL TAPEFebruary 9, 1990
K894367LEUKOSPORT(TM) ADHESIVE TAPENovember 15, 1989