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
25–48 of 102
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 19d
Cleared Jan 30, 1984
COMFEEL PASTE
K833565
Coloplast A/S
Gastroenterology & Urology · 110d
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 16, 1981
SUR-FIT LOOP OSTOMY O.R. SET
K811240
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 09, 1981
SUR-FIT DISPOSABLE CONVEX INSERT
K811239
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared May 21, 1981
SUR-FIT DISPOSABLE FANGE CAP
K811163
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 23d
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
VANCE UROSTOMY APPLIANCE
K803048
Vance Products, Inc.
Gastroenterology & Urology · 21d
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