| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| SmartBag (SmartPouch) (K181643) | 11 Health Technologies Limited | 2018-11-16 |
| OSTOM-I ALERT (K140938) | 11 Health and Technologies, LLC | 2014-10-10 |
| LAKE OSTOMY CARE SET (K922730) | Lake Medical Products, Inc. | 1993-12-30 |
| ODOR-END EMERGENCY CLEAN UP POWDER (K882878) | Cdc Products Corp. | 1988-12-08 |
| CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (K881636) | Coloplast A/S | 1988-07-13 |
| EMERGENCY-CLEAN UP(TM) ECP (K880306) | Cdc Products Corp. | 1988-05-20 |
| COMBINATION NITE DRAINAGE UNIT (K872294) | Arnold Technologies | 1987-12-29 |
| 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (K873929) | Midwest Medical Co. | 1987-12-03 |
| ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (K871526) | Cox Family Laboratories, Inc. | 1987-10-13 |
| OSTO-PURE (K871738) | Clearchem Corp. | 1987-08-12 |
| PALEX (R) OSTOMY (K871628) | Industrias Palex C/O Dma Med-Chem Corp. | 1987-07-08 |
| E-Z LOOP (K870577) | John F. Greer Co., Inc. | 1987-04-17 |
| EZ TAC FILTER (K870531) | John F. Greer Co., Inc. | 1987-04-10 |
| PERSONAL PUNCH (K870136) | Arnold Technologies | 1987-04-01 |
| ULTRA-GEL - #4083 (K864189) | John F. Greer Co., Inc. | 1986-12-04 |
| BARD IRYFIX(TM) STOMA CAP (K862631) | C.R. Bard, Inc. | 1986-10-16 |
| COLOPLAST CONVEX RING (K861070) | Coloplast A/S | 1986-06-16 |
| DURAHESIVE PROTECTIVE BARRIER WIPE (K855019) | Convatec, A Division of E.R. Squibb & Sons | 1986-04-16 |
| MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (K854726) | Pfizer, Inc. | 1986-02-24 |
| DURAHESIVE WAFER WITH FLANGE (K855018) | Convatec, A Division of E.R. Squibb & Sons | 1986-02-04 |
| CONFIDENT ODOR ELIMINATOR (K852471) | Hallmark Industries, Inc. | 1986-01-14 |
| OSTOMY BAGS COLOSTOMY (K851679) | Dbt Medical , Ltd. | 1985-06-27 |
| OSTOMY BAGS ILEOSTOMY (K851680) | Dbt Medical , Ltd. | 1985-06-27 |
| OSTOMY BAGS URETHEROSTOMY (K851678) | Dbt Medical , Ltd. | 1985-06-27 |
| STOMAHESIVE SKIN BARRIER STERILE (K851840) | Convatec, A Division of E.R. Squibb & Sons | 1985-06-24 |
| JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT (K852297) | Johnson & Johnson Professionals, Inc. | 1985-06-12 |
| DISPOSABLE UROSTOMY POUCH (K850750) | Biolog, Inc. | 1985-05-23 |
| BARD PERISTOMAL PASTE (K851398) | C.R. Bard, Inc. | 1985-05-23 |
| DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY (K850751) | Biolog, Inc. | 1985-05-23 |
| UNITED SKIN BARRIERS (K844938) | Pfizer, Inc. | 1985-01-18 |
| COLOPLAST URO 2002 UROSTOMY SYSTEM (K844685) | Coloplast A/S | 1985-01-08 |
| JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN (K844406) | Johnson & Johnson Professionals, Inc. | 1984-11-29 |
| UNITED SKIN BARRIERS (K844046) | Howmedica Corp. | 1984-11-29 |
| SUR-FIT IRRIGATION ADAPTER FACEPLATE (K842398) | Convatec, A Division of E.R. Squibb & Sons | 1984-10-01 |
| OSTOMY OR UROSTOMY ABDOMINAL BELT OS (K842119) | Atlas Surgical Belt Co., Inc. | 1984-09-10 |
| OSTOMY FREEDOM KIT (K841173) | Ellenberg Assoc. | 1984-07-09 |
| SWEEN-A-PEEL PERISTOMAL WAFERS (K840723) | Sween Corp. | 1984-05-07 |
| ACTIVE LIFE ONE-PIECE CLOSED-END POUCH (K840568) | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 |
| ACTIVE LIFE ONE-PIECE STOMA CAP (K840567) | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 |
| COMFEEL PROTECTIVE FILM (K833567) | Coloplast A/S | 1984-05-02 |
| BANGORT LIFESTYLE COLOSTOMY POUCHES (K841029) | Howmedica Corp. | 1984-04-04 |
| MC 2000 OSTOMY POUCHES (K840269) | Coloplast A/S | 1984-04-02 |
| FILTRODER FILTERS (K840267) | Coloplast A/S | 1984-04-02 |
| MC 2002 OSTOMY POUCHES & SKIN FLANGES (K840265) | Coloplast A/S | 1984-04-02 |
| BARD KARAYA GUM WASHERS (K834575) | C.R. Bard, Inc. | 1984-02-04 |
| SUR-FIT UROSTOMY POUCH W/ACCUSEAL (K840166) | Convatec, A Division of E.R. Squibb & Sons | 1984-02-04 |
| COMFEEL PASTE (K833565) | Coloplast A/S | 1984-01-30 |
| STERILE DRAINAGE SYSTEM (K833571) | Coloplast A/S | 1984-01-30 |
| COMFEEL CLEANSER (K833566) | Coloplast A/S | 1983-12-27 |
| COMFEEL BARRIER CREAM (K833569) | Coloplast A/S | 1983-12-27 |
| ACTIVE LIFE (K833625) | Convatec, A Division of E.R. Squibb & Sons | 1983-11-28 |
| COLOSTOMY BAG (K830841) | C & D Colostomy Pad Corp. | 1983-07-19 |
| SUR-FIT FLEXIBLE (K830945) | Convatec, A Division of E.R. Squibb & Sons | 1983-04-12 |
| BARD PROTECTIVE BARRIER FILM (K821271) | C.R. Bard, Inc. | 1982-07-02 |
| HOLLISTER CATHETER ACCESS. PORT (K821680) | Hollister, Inc. | 1982-06-24 |
| DEEP CONVEX FACE PLATE (K820493) | Smith'S Ostomy Products, Inc. | 1982-03-10 |
| LAMINATED KARAYA GUM WASHERS (K820167) | Atlantic Surgical | 1982-02-18 |
| FECAL INCONTINENCE COLLATOR (K813270) | Hollister, Inc. | 1981-12-14 |
| TWO PIECE OSTOMY SYSTEM (K813269) | Hollister, Inc. | 1981-12-03 |
| WOUND DRAINAGE MANAGEMENT SYSTEMS (K813080) | Howmedica Corp. | 1981-11-17 |
| CANCEL (K812582) | Bio Systems, Inc. | 1981-09-23 |
| SUR-FIT LOOP OSTOMY O.R. SET (K811240) | E. R. Squibb & Sons, Inc. | 1981-06-16 |
| ECONOMY OPEN END DRAINAGE BAG (K811300) | Economy Plus | 1981-06-09 |
| SUR-FIT DISPOSABLE CONVEX INSERT (K811239) | E. R. Squibb & Sons, Inc. | 1981-06-09 |
| FORMULATION CHANGE IN UNITED SKIN BARR (K810726) | Howmedica Corp. | 1981-06-02 |
| SUR-FIT DISPOSABLE FANGE CAP (K811163) | E. R. Squibb & Sons, Inc. | 1981-05-21 |
| DRAINING-WOUND MGMT. SYSTEM (K810812) | Johnson & Johnson Professionals, Inc. | 1981-04-17 |
| HOLLISEAL OSTOMY SKIN BARRIER (K810807) | Hollister, Inc. | 1981-04-07 |
| HOLLISTER SKIN BARRIER B (K810710) | Hollister, Inc. | 1981-04-07 |
| HOLLISTER SKIN BARRIER A (K810709) | Hollister, Inc. | 1981-04-07 |
| VANCE UROSTOMY APPLIANCE (K803048) | Vance Products, Inc. | 1980-12-22 |
| ADHESIVE PERISTOMAL COVERING W/WO CONN. (K803082) | Johnson & Johnson Professionals, Inc. | 1980-12-22 |
| CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON (K802677) | Johnson & Johnson Professionals, Inc. | 1980-11-12 |
| OSTOMATE THIRD HAND (K802424) | Smith'S Ostomy Products, Inc. | 1980-10-31 |
| SUR-FIT SYSTEM STERILE O.R. SETS (K801703) | E. R. Squibb & Sons, Inc. | 1980-09-09 |
| SUR-FIT SYSTEM PRE-OPERATION SET (K801702) | E. R. Squibb & Sons, Inc. | 1980-08-27 |
| HOLLISTER KARAYA SEAL RING (K801503) | Hollister, Inc. | 1980-08-13 |
| SUPER BANISH DEODORANT (K801471) | Howmedica Corp. | 1980-07-28 |
| STOMAHESIVE STERILE WAFER (K800750) | Squibb & Sons, Inc. | 1980-05-08 |
| SUR-FIT UROSTOMY POUCH & URINARY BAG (K800495) | E. R. Squibb & Sons, Inc. | 1980-04-08 |
| STOMAHESIVE POWDER (K792382) | E. R. Squibb & Sons, Inc. | 1979-12-20 |
| BONGORT ODOR BARRIER DRAIN (K792381) | Howmedica Corp. | 1979-12-10 |
| FEATHER-LITE URINARY DIV. POUCH (K792139) | Howmedica Corp. | 1979-11-13 |
| HOLLISTER STOMA POUCH WITH MICRO ADHES (K791535) | Hollister, Inc. | 1979-10-26 |
| HOLLISTER KARAYA PASTE (K791525) | Hollister, Inc. | 1979-10-26 |
| HOLLISTER STOMA POUCH SKIN BARRIER (K791526) | Hollister, Inc. | 1979-10-26 |
| HOLLISTER UROSTOMY POUCH (K791534) | Hollister, Inc. | 1979-10-09 |
| COLOPLAST CARBON GAS FILTER (K791581) | C.R. Bard, Inc. | 1979-10-02 |
| OSTOMY APPLIANCE W/DEODORIZING FILTER (K781373) | Hollister, Inc. | 1978-09-20 |
| OSTOMY APPLIANCE BELT (K781088) | E. R. Squibb & Sons, Inc. | 1978-08-18 |
| K-Z CONCENTRATE (K781011) | K-Zyme Labs, Inc. | 1978-08-17 |
| ILEX STOMA SEAL AND PROTECTIVE CREAM (K780473) | Virgil Pichierri | 1978-05-16 |
| SNAP-FIT (K780511) | E. R. Squibb & Sons, Inc. | 1978-04-21 |
| ACTIVE-LIFE (K780454) | E. R. Squibb & Sons, Inc. | 1978-04-21 |
| COLORPLAST TRANSVERSE SYSTEM (K771775) | C.R. Bard, Inc. | 1977-09-30 |
| STOMA BAG W/SKIN BARRIER SEAL RING (K770439) | Hollister, Inc. | 1977-04-15 |
| STOMA BAGS W/MICROPOROUS ADHESIVE (K770178) | Hollister, Inc. | 1977-02-01 |
| RECTAL TUBE DEVICE (K760886) | Van Sickle Plastics Co. | 1976-12-09 |
| BONGORT ILEOSTOMY POUCH (K760878) | Howmedica Corp. | 1976-12-02 |