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Panels › Gastroenterology, Urology › Product code EXB · Class 1

Collector, Ostomy

Regulation 876.5900

0510(k)s in 12 months (102 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
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Top companies in EXB

Decided510(k)Device and applicantCode
Oct 6, 2025K252140Heylo™ System
Coloplast Corp.
EXB
Nov 16, 2018K181643SmartBag (SmartPouch)
11 Health Technologies Limited, GB
EXB
Oct 10, 2014K140938OSTOM-I ALERT
11 Health and Technologies, LLC
EXB
Dec 30, 1993K922730LAKE OSTOMY CARE SET
Lake Medical Products, Inc.
EXB
Dec 8, 1988K882878ODOR-END EMERGENCY CLEAN UP POWDER
Cdc Products Corp.
EXB
Jul 13, 1988K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
Coloplast A/S
EXB
May 20, 1988K880306EMERGENCY-CLEAN UP(TM) ECP
Cdc Products Corp.
EXB
Dec 29, 1987K872294COMBINATION NITE DRAINAGE UNIT
Arnold Technologies
EXB
Dec 3, 1987K873929'CATCH-IT' OR FECAL CONTAINMENT DEVICE
Midwest Medical Co.
EXB
Oct 13, 1987K871526ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
Cox Family Laboratories, Inc.
EXB
Aug 12, 1987K871738OSTO-PURE
Clearchem Corp.
EXB
Jul 8, 1987K871628PALEX (R) OSTOMY
Industrias Palex C/O Dma Med-Chem Corp.
EXB
Apr 17, 1987K870577E-Z LOOP
John F. Greer Co., Inc.
EXB
Apr 10, 1987K870531EZ TAC FILTER
John F. Greer Co., Inc.
EXB
Apr 1, 1987K870136PERSONAL PUNCH
Arnold Technologies
EXB
Dec 4, 1986K864189ULTRA-GEL - #4083
John F. Greer Co., Inc.
EXB
Oct 16, 1986K862631BARD IRYFIX(TM) STOMA CAP
C.R. Bard, Inc.
EXB
Jun 16, 1986K861070COLOPLAST CONVEX RING
Coloplast A/S
EXB
Apr 16, 1986K855019DURAHESIVE PROTECTIVE BARRIER WIPE
Convatec, A Division of E.R. Squibb & Sons
EXB
Feb 24, 1986K854726MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
Pfizer, Inc.
EXB
Feb 4, 1986K855018DURAHESIVE WAFER WITH FLANGE
Convatec, A Division of E.R. Squibb & Sons
EXB
Jan 14, 1986K852471CONFIDENT ODOR ELIMINATOR
Hallmark Industries, Inc.
EXB
Jun 27, 1985K851680OSTOMY BAGS ILEOSTOMY
Dbt Medical , Ltd., GB
EXB
Jun 27, 1985K851679OSTOMY BAGS COLOSTOMY
Dbt Medical , Ltd., GB
EXB
Jun 27, 1985K851678OSTOMY BAGS URETHEROSTOMY
Dbt Medical , Ltd., GB
EXB
Jun 24, 1985K851840STOMAHESIVE SKIN BARRIER STERILE
Convatec, A Division of E.R. Squibb & Sons
EXB
Jun 12, 1985K852297JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
Johnson & Johnson Professionals, Inc.
EXB
May 23, 1985K851398BARD PERISTOMAL PASTE
C.R. Bard, Inc.
EXB
May 23, 1985K850751DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY
Biolog, Inc.
EXB
May 23, 1985K850750DISPOSABLE UROSTOMY POUCH
Biolog, Inc.
EXB
Jan 18, 1985K844938UNITED SKIN BARRIERS
Pfizer, Inc.
EXB
Jan 8, 1985K844685COLOPLAST URO 2002 UROSTOMY SYSTEM
Coloplast A/S
EXB
Nov 29, 1984K844406JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
Johnson & Johnson Professionals, Inc.
EXB
Nov 29, 1984K844046UNITED SKIN BARRIERS
Howmedica Corp.
EXB
Oct 1, 1984K842398SUR-FIT IRRIGATION ADAPTER FACEPLATE
Convatec, A Division of E.R. Squibb & Sons
EXB
Sep 10, 1984K842119OSTOMY OR UROSTOMY ABDOMINAL BELT OS
Atlas Surgical Belt Co., Inc.
EXB
Jul 9, 1984K841173OSTOMY FREEDOM KIT
Ellenberg Assoc.
EXB
May 7, 1984K840723SWEEN-A-PEEL PERISTOMAL WAFERS
Sween Corp.
EXB
May 2, 1984K840568ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
Convatec, A Division of E.R. Squibb & Sons
EXB
May 2, 1984K840567ACTIVE LIFE ONE-PIECE STOMA CAP
Convatec, A Division of E.R. Squibb & Sons
EXB
May 2, 1984K833567COMFEEL PROTECTIVE FILM
Coloplast A/S
EXB
Apr 4, 1984K841029BANGORT LIFESTYLE COLOSTOMY POUCHES
Howmedica Corp.
EXB
Apr 2, 1984K840269MC 2000 OSTOMY POUCHES
Coloplast A/S
EXB
Apr 2, 1984K840267FILTRODER FILTERS
Coloplast A/S
EXB
Apr 2, 1984K840265MC 2002 OSTOMY POUCHES & SKIN FLANGES
Coloplast A/S
EXB
Feb 4, 1984K840166SUR-FIT UROSTOMY POUCH W/ACCUSEAL
Convatec, A Division of E.R. Squibb & Sons
EXB
Feb 4, 1984K834575BARD KARAYA GUM WASHERS
C.R. Bard, Inc.
EXB
Jan 30, 1984K833571STERILE DRAINAGE SYSTEM
Coloplast A/S
EXB
Jan 30, 1984K833565COMFEEL PASTE
Coloplast A/S
EXB
Dec 27, 1983K833569COMFEEL BARRIER CREAM
Coloplast A/S
EXB

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