Coloplast Corp. - FDA 510(k) Cleared Devices
56
Total
49
Cleared
0
Denied
56 devices
Cleared
May 11, 1992
SUOENA AFFINITY (TM) MODEL #802
General & Plastic Surgery
41d
Cleared
Jan 14, 1992
AMOENA AFFINITY MODEL #802
General & Plastic Surgery
46d
Cleared
Oct 11, 1990
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
General & Plastic Surgery
20d
Cleared
Jan 08, 1987
AMOENA BREAST FORMS
General & Plastic Surgery
31d
Cleared
Jan 08, 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
General & Plastic Surgery
31d
Cleared
Sep 30, 1985
AMOENA BREAST FORMS
General & Plastic Surgery
17d