| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| Luja Coudé (K251116) | Coloplast Corp. | 2025-06-27 |
| Luja Set (K250270) | Coloplast Corp. | 2025-04-17 |
| SureCath Set (K242049) | Coloplast Corp. | 2024-11-26 |
| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173) | Coloplast Corp. | 2024-11-12 |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |
| Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) (K231953) | Coloplast Corp. | 2024-03-22 |
| Luja Coude (20108 Male CH18 - large packaging) (K233101) | Coloplast Corp. | 2023-10-26 |
| ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits (K213185) | Coloplast Corp. | 2022-06-08 |
| Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911) | Coloplast Corp. | 2022-03-10 |
| NovoFlow Reinforced Ureteral Stent (K213186) | Coloplast Corp. | 2022-02-16 |
| Vortek Single Loop Ureteral Stent (K201436) | Coloplast Corp. | 2021-02-25 |
| In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165) | Coloplast Corp. | 2020-12-17 |
| In-Ka Ureteral Balloon Dilatation Catheter (K201007) | Coloplast Corp. | 2020-06-11 |
| SabreLine and SabreGuard Laser Fibers (K182831) | Coloplast Corp. | 2018-12-10 |
| ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent (K180469) | Coloplast Corp. | 2018-11-06 |
| Ureteric Catheters (K182122) | Coloplast Corp. | 2018-10-04 |
| VORTEK URETERAL DOUBLE LOOP STENT (K180057) | Coloplast Corp. | 2018-03-09 |
| Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043) | Coloplast Corp. | 2017-12-21 |
| VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS (K170362) | Coloplast Corp. | 2017-11-15 |
| BIOSOFT DUO DOUBLE LOOP URETERAL STENTS (K170422) | Coloplast Corp. | 2017-11-02 |
| Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) | Coloplast Corp. | 2017-08-17 |
| SpeediCath Flex Coude (K161672) | Coloplast Corp. | 2016-09-29 |
| RESTORELLE M, RESTORELLE XL (K132061) | Coloplast Corp. | 2013-08-02 |
| NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (K122968) | Coloplast Corp. | 2012-12-18 |
| RESTORELLE L (K122440) | Coloplast Corp. | 2012-11-19 |
| SPEEDICATH COMPACT SET (12 FR) (K121457) | Coloplast Corp. | 2012-10-02 |
| EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386) | Coloplast Corp. | 2011-09-08 |
| SPEEDICATH COMPACT (K072808) | Coloplast Corp. | 2007-11-09 |
| COLOPLAST OSTOMY ROD, MODEL 12814 (K052229) | Coloplast Corp. | 2006-10-13 |
| CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) (K033869) | Coloplast Corp. | 2004-05-17 |
| CONTREET FOAM ADHESIVE/NON-ADHESIVE (K022416) | Coloplast Corp. | 2003-02-03 |
| SPEEDICATH (K023254) | Coloplast Corp. | 2003-01-27 |
| CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (K013525) | Coloplast Corp. | 2002-10-04 |
| MODIFICATION TO WOUN'DRES (K991202) | Coloplast Corp. | 1999-06-04 |
| COMPEED PSORIASIS DRESSING (K982493) | Coloplast Corp. | 1999-01-28 |
| COMFEEL SEASORB DRESSING (K983519) | Coloplast Corp. | 1998-12-30 |
| BIATAIN FOAM DRESSING (K983163) | Coloplast Corp. | 1998-12-16 |
| BIATAIN FOAM ADHESIVE DRESSING (K983173) | Coloplast Corp. | 1998-12-16 |
| SWEEN WOUN'DRES (K983042) | Coloplast Corp. | 1998-11-25 |
| CONVEEN EASICATH SET (K973070) | Coloplast Corp. | 1997-11-06 |
| COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597) | Coloplast Corp. | 1997-07-29 |
| CONVEEN URINE BAG - STERILE (K955609) | Coloplast Corp. | 1995-12-29 |
| COMFEEL:ALGINATE FILLER (K954857) | Coloplast Corp. | 1995-11-14 |
| CONVEEN LEG BAG STRAP (K953783) | Coloplast Corp. | 1995-09-13 |
| SKIN SUPPORT PREP PAD (K923351) | Coloplast Corp. | 1992-09-14 |
| SUOENA AFFINITY (TM) MODEL #802 (K921535) | Coloplast Corp. | 1992-05-11 |
| AMOENA AFFINITY MODEL #802 (K915382) | Coloplast Corp. | 1992-01-14 |
| NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (K904316) | Coloplast Corp. | 1990-10-11 |
| AMOENA BREAST FORMS (K864785) | Coloplast Corp. | 1987-01-08 |
| PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (K864786) | Coloplast Corp. | 1987-01-08 |
| AMOENA BREAST FORMS (K853822) | Coloplast Corp. | 1985-09-30 |