EXB · Class I · 21 CFR 876.5900

FDA Product Code EXB: Collector, Ostomy

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

102
Total
102
Cleared
66d
Avg days
1976
Since
102 devices
25–48 of 102
Cleared Jan 30, 1984
STERILE DRAINAGE SYSTEM
K833571
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Dec 27, 1983
COMFEEL CLEANSER
K833566
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Dec 27, 1983
COMFEEL BARRIER CREAM
K833569
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Nov 28, 1983
ACTIVE LIFE
K833625
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 45d
Cleared Apr 12, 1983
SUR-FIT FLEXIBLE
K830945
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 19d
Cleared Jul 02, 1982
BARD PROTECTIVE BARRIER FILM
K821271
C.R. Bard, Inc.
Gastroenterology & Urology · 60d
Cleared Jun 24, 1982
HOLLISTER CATHETER ACCESS. PORT
K821680
Hollister, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 14, 1981
FECAL INCONTINENCE COLLATOR
K813270
Hollister, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 03, 1981
TWO PIECE OSTOMY SYSTEM
K813269
Hollister, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080
Howmedica Corp.
Gastroenterology & Urology · 15d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared Apr 17, 1981
DRAINING-WOUND MGMT. SYSTEM
K810812
Johnson & Johnson Professionals, Inc.
Chemistry · 24d
Cleared Apr 07, 1981
HOLLISTER SKIN BARRIER A
K810709
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 07, 1981
HOLLISTER SKIN BARRIER B
K810710
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 07, 1981
HOLLISEAL OSTOMY SKIN BARRIER
K810807
Hollister, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 22, 1980
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 12, 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 14d
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 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