Coloplast A/S - FDA 510(k) Cleared Devices
71
Total
68
Cleared
0
Denied
45 devices
Cleared
Feb 09, 1990
CONVEEN INTERMITTENT CATHETERS
Gastroenterology & Urology
149d
Cleared
Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
Gastroenterology & Urology
90d
Cleared
Jun 10, 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
Gastroenterology & Urology
47d
Cleared
Jun 10, 1987
CONVEEN(R) LEG-BAG (600 ML)
Gastroenterology & Urology
44d
Cleared
Oct 16, 1986
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
Gastroenterology & Urology
16d
Cleared
Jun 16, 1986
COLOPLAST CONVEX RING
Gastroenterology & Urology
88d
Cleared
Dec 13, 1985
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
Gastroenterology & Urology
28d
Cleared
Jan 08, 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
Gastroenterology & Urology
39d
Cleared
Jan 08, 1985
COLOPLAST URO 2002 UROSTOMY SYSTEM
Gastroenterology & Urology
39d
Cleared
May 02, 1984
COMFEEL PROTECTIVE FILM
Gastroenterology & Urology
203d
Cleared
Apr 05, 1984
IRRIGATION SYSTEM
Gastroenterology & Urology
73d
Cleared
Apr 02, 1984
MC 2002 OSTOMY POUCHES & SKIN FLANGES
Gastroenterology & Urology
70d
Cleared
Apr 02, 1984
FILTRODER FILTERS
Gastroenterology & Urology
70d
Cleared
Apr 02, 1984
MC 2000 OSTOMY POUCHES
Gastroenterology & Urology
70d
Cleared
Jan 30, 1984
COMFEEL PASTE
Gastroenterology & Urology
110d
Cleared
Jan 30, 1984
COLOPLAST BABY URINE COLLECTORS
Gastroenterology & Urology
110d
Cleared
Jan 30, 1984
STERILE DRAINAGE SYSTEM
Gastroenterology & Urology
110d
Cleared
Jan 23, 1984
K-FLEX OSTOMY POUCH
Gastroenterology & Urology
Cleared
Dec 27, 1983
COMFEEL CLEANSER
Gastroenterology & Urology
76d
Cleared
Dec 27, 1983
COMFEEL BARRIER CREAM
Gastroenterology & Urology
76d