EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

Leading manufacturers include Hollister, Inc., Coloplast A/S and E. R. Squibb & Sons, Inc..

102
Total
102
Cleared
66d
Avg days
1976
Since
102 devices
49–72 of 102
Cleared Sep 09, 1980
SUR-FIT SYSTEM STERILE O.R. SETS
K801703
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 27, 1980
SUR-FIT SYSTEM PRE-OPERATION SET
K801702
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 34d
Cleared Aug 13, 1980
HOLLISTER KARAYA SEAL RING
K801503
Hollister, Inc.
Gastroenterology & Urology · 47d
Cleared Jul 28, 1980
SUPER BANISH DEODORANT
K801471
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Apr 08, 1980
SUR-FIT UROSTOMY POUCH & URINARY BAG
K800495
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Dec 20, 1979
STOMAHESIVE POWDER
K792382
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 10, 1979
BONGORT ODOR BARRIER DRAIN
K792381
Howmedica Corp.
Gastroenterology & Urology · 14d
Cleared Nov 13, 1979
FEATHER-LITE URINARY DIV. POUCH
K792139
Howmedica Corp.
Gastroenterology & Urology · 22d
Cleared Oct 26, 1979
HOLLISTER KARAYA PASTE
K791525
Hollister, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1979
HOLLISTER STOMA POUCH SKIN BARRIER
K791526
Hollister, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1979
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535
Hollister, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 09, 1979
HOLLISTER UROSTOMY POUCH
K791534
Hollister, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 02, 1979
COLOPLAST CARBON GAS FILTER
K791581
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Sep 20, 1978
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373
Hollister, Inc.
Gastroenterology & Urology · 44d
Cleared Aug 18, 1978
OSTOMY APPLIANCE BELT
K781088
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 21, 1978
ACTIVE-LIFE
K780454
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 21, 1978
SNAP-FIT
K780511
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 30, 1977
COLORPLAST TRANSVERSE SYSTEM
K771775
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Apr 15, 1977
STOMA BAG W/SKIN BARRIER SEAL RING
K770439
Hollister, Inc.
Gastroenterology & Urology · 39d
Cleared Feb 01, 1977
STOMA BAGS W/MICROPOROUS ADHESIVE
K770178
Hollister, Inc.
Gastroenterology & Urology · 6d
Cleared Dec 02, 1976
BONGORT ILEOSTOMY POUCH
K760878
Howmedica Corp.
Gastroenterology & Urology · 42d
Cleared Nov 23, 1976
SILASTIC ILEAL RESERVOIR CATHETER
K760860
Dow Corning Corp. Healthcare Industries Materials
Gastroenterology & Urology · 36d
Cleared Oct 15, 1976
BONGORT SPECIAL ODORPROOF DRAIN
K760735
Howmedica Corp.
Gastroenterology & Urology · 17d