Coloplast A/S
Medical device manufacturer in Minneapolis, MN.
72510(k) clearances
0PMA approvals
0recalls
Device types
- EXB Collector, Ostomy 11
- FRO Dressing, Wound, Drug 6
- KNX Collector, Urine, (And Accessories) For… 5
- KMF Bandage, Liquid 5
- FED Endoscopic Access Overtube, Gastroenterology… 4
- KNT Tubes, Gastrointestinal (And Accessories) 4
- OTM Mesh, Surgical, For Stress Urinary… 4
- OTO Mesh, Surgical, Synthetic, Urogynecologic… 3
- GBM Catheter, Urethral 3
- KCZ Prosthesis, Breast, External, Used With… 2
- PAH Mesh, Surgical, Synthetic, Urogynecologic… 2
- EXJ Device, Incontinence, Urosheath Type, Sterile 2
- OCY Endoscopic Guidewire, Gastroenterology-Urolo… 2
- EXD Irrigator, Ostomy 2
- EXI Device, Paste-On For Incontinence, Sterile 1
- FAQ Bag, Urine Collection, Leg, For External… 1
- FBK Endoscopic Injection Needle… 1
- KGX Tape And Bandage, Adhesive 1
- EZD Catheter, Straight 1
- KOZ Beads, Hydrophilic, For Wound Exudate… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262045 | Luja SoftEZD · Special | 07/07/2026SE |
| K221874 | Altis Single Incision Sling SystemPAH · Special | 02/15/2023SE |
| K220420 | Saffron Fixation SystemPBQ · Traditional | 06/10/2022SE |
| K191536 | Biatain Silicone AgFRO · Traditional | 02/21/2020SE |
| K181811 | ReTrace Ureteral Access SheathFED · Special | 09/07/2018SE |
| K173527 | Digitex Delivery DevicePWI · Traditional | 02/12/2018SE |
| K140310 | Peristeen Anal Irrigation SystemKNT · Traditional | 09/03/2015SE |
| K150935 | SpeediCath Compact EveGBM · Traditional | 07/02/2015SE |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | 05/27/2015SE |
| K143182 | Speedicath Compact MaleGBM · Traditional | 01/20/2015SE |
| K140523 | Re-Trace Ureteral Access Sheath, 12/14 Ch/Fr, Length 35 CM, Length 45 CMFED · Special | 07/24/2014SE |
| K140116 | Restorelle Y Contour MeshOTO · Special | 02/12/2014SE |
| K131072 | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | 07/09/2013SE |
| K123914 | Restorelle Y ContourOTO · Special | 03/05/2013SE |
| K123675 | Re-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access…FED · Traditional | 03/01/2013SE |
| K121562 | Altis Single Incision Cling SystemPAH · Traditional | 11/05/2012SE |
| K121458 | Speedicath Compact Set (12/18 FR)GBM · Traditional | 10/01/2012SE |
| K121833 | Ostomy Irrigation SetEXD · Special | 07/16/2012SE |
| K112860 | Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen…KNT · Traditional | 06/08/2012SE |
| K120284 | Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…NEW · Traditional | 05/23/2012SE |
| K112322 | Restorelle Polypropylene Y MeshOTO · Traditional | 05/17/2012SE |
| K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesFRO · Special | 04/05/2012SE |
| K113496 | Virture Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional | 02/14/2012SE |
| K111881 | Virtue Male Sling System and Alexis(R) Wound Retractor KitOTM · Traditional | 08/17/2011SE |
| K111233 | Supris Retropubic Sling SystemOTN · Special | 06/24/2011SE |
| K103254 | Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter…KNT · Traditional | 01/31/2011SE |
| K103568 | Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshFTL · Special | 12/22/2010SE |
| K102485 | Re-Trace Ureteral Access SheathFED · Traditional | 10/18/2010SE |
| K101297 | Virtue Ventral Urethral Elevation Sling System Model 50020OTM · Special | 06/03/2010SE |
| K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFRO · Special | 02/17/2010SE |
| K083770 | Coloplast Peristeen Anal Irrigation (Pai) SystemKNT · Traditional | 11/23/2009SE |
| K083499 | Exair Anterior and Posterior Prolapse Repair SystemsOTP · Traditional | 05/08/2009SE |
| K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020OTM · Special | 05/07/2009SE |
| K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070FBK · Traditional | 04/23/2009SE |
| K953497 | Comfeel:Alginate DressingKMF · Traditional | 09/29/1995SE |
| K946243 | Conveen(R) Self-Sealing Urisheath Male External CatheterEXJ · Traditional | 02/13/1995SE |
| K925376 | Comfeel(R) Wound Dressing SDKMF · Traditional | 03/16/1993SE |
| K924406 | Conveen(R) Leg BAG(500 ML)FAQ · Traditional | 10/30/1992SE |
| K924407 | Conveen(R) Self-Sealing Urisheath Male Exter CathEXJ · Traditional | 09/23/1992SE |
| K922466 | Comfeel Wound Dressing SDKMF · Traditional | 08/17/1992SE |
| K922461 | Comfeel Wound Dressing OrdKMF · Traditional | 08/17/1992SE |
| K920925 | Comfeel Contour DressingKMF · Traditional | 05/28/1992SE |
| K915246 | Conveen(R) Urisheath and Uriliner(Male Exter Cath)EXI · Traditional | 02/05/1992SE |
| K904085 | Ella Breast FormKCZ · Traditional | 10/31/1990SE |
| K904086 | Discrene Self-Supporting Breast FormKCZ · Traditional | 10/02/1990SE |
| K895548 | Conveen Intermittent CathetersKOD · Traditional | 02/09/1990SE |
| K894916 | Comfeel Transparent DressingKGX · Traditional | 09/26/1989SE |
| K883588 | Compeed Athletic DressingFRO · Traditional | 09/22/1988SN |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | 07/13/1988SE |
| K873669 | Comfeel Ulcus Ulcer Care SystemFRO · Traditional | 11/17/1987SN |
| K871643 | Conveen(R) Leg-Bag (600 ML)KNX · Traditional | 06/10/1987SE |
| K871610 | Conveen(R) Night Drainage Bag (2000 ML)KNX · Traditional | 06/10/1987SE |
| K863830 | Conseal(Tm) Colostomy Continence SystemEZQ · Traditional | 10/16/1986SE |
| K861070 | Coloplast Convex RingEXB · Traditional | 06/16/1986SE |
| K854580 | Conveen Self-Sealing Urisheath Male External CathKNX · Traditional | 12/13/1985SE |
| K844685 | Coloplast Uro 2002 Urostomy SystemEXB · Traditional | 01/08/1985SE |
| K844684 | Coloplast Uro 2002 Night Drainage SystemKNX · Traditional | 01/08/1985SE |
| K834343 | Comfeel PowderKOZ · Traditional | 11/08/1984SE |
| K840438 | Comfeel Ulcus SheetFRO · Traditional | 11/07/1984SE |
| K840362 | Comfeel Paste · Traditional | 11/07/1984SE |
| K833567 | Comfeel Protective FilmEXB · Traditional | 05/02/1984SE |
| K840268 | Irrigation SystemEXD · Traditional | 04/05/1984SE |
| K840269 | MC 2000 Ostomy PouchesEXB · Traditional | 04/02/1984SE |
| K840267 | Filtroder FiltersEXB · Traditional | 04/02/1984SE |
| K840265 | MC 2002 Ostomy Pouches & Skin FlangesEXB · Traditional | 04/02/1984SE |
| K833571 | Sterile Drainage SystemEXB · Traditional | 01/30/1984SE |
| K833570 | Coloplast Baby Urine CollectorsKNX · Traditional | 01/30/1984SE |
| K833565 | Comfeel PasteEXB · Traditional | 01/30/1984SE |
| K840266 | K-Flex Ostomy Pouch · Traditional | 01/23/1984SESP |
| K833569 | Comfeel Barrier CreamEXB · Traditional | 12/27/1983SE |
| K833566 | Comfeel CleanserEXB · Traditional | 12/27/1983SE |
| K832908 | Comfeel Protective RingsEYF · Traditional | 12/12/1983SE |