Company ยท US
Coloplast A/S
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2026. Name variants (Inc, Corp, punctuation) are merged.
72510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EXB | Collector, Ostomy | 11 |
| FRO | Dressing, Wound, Drug | 6 |
| KMF | Bandage, Liquid | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | 4 |
| GBM | Catheter, Urethral | 3 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 3 |
| EXD | Irrigator, Ostomy | 2 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 2 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 2 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 2 |
| EXI | Device, Paste-On For Incontinence, Sterile | 1 |
| EYF | Protector, Wound, Plastic | 1 |
| EZD | Catheter, Straight | 1 |
| EZQ | Pouch, Colostomy | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 2026 | K262045 | Luja Soft Coloplast A.S. | EZD |
| Feb 15, 2023 | K221874 | Altis Single Incision Sling System Coloplast A/S | PAH |
| Jun 10, 2022 | K220420 | Saffron Fixation System Coloplast A/S | PBQ |
| Feb 21, 2020 | K191536 | Biatain Silicone Ag Coloplast A/S, DK | FRO |
| Sep 7, 2018 | K181811 | ReTrace Ureteral Access Sheath Coloplast A/S | FED |
| Feb 12, 2018 | K173527 | Digitex Delivery Device Coloplast A/S | PWI |
| Sep 3, 2015 | K140310 | Peristeen Anal Irrigation System Coloplast A/S | KNT |
| Jul 2, 2015 | K150935 | SpeediCath Compact Eve Coloplast A/S | GBM |
| May 27, 2015 | K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic G Coloplast A/S | OCY |
| Jan 20, 2015 | K143182 | Speedicath Compact Male Coloplast A/S | GBM |
| Jul 24, 2014 | K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM Coloplast A/S | FED |
| Feb 12, 2014 | K140116 | RESTORELLE Y CONTOUR MESH Coloplast A/S | OTO |
| Jul 9, 2013 | K131072 | ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC Coloplast A/S | OCY |
| Mar 5, 2013 | K123914 | RESTORELLE Y CONTOUR Coloplast A/S | OTO |
| Mar 1, 2013 | K123675 | RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR Coloplast A/S | FED |
| Nov 5, 2012 | K121562 | ALTIS SINGLE INCISION CLING SYSTEM Coloplast A/S | PAH |
| Oct 1, 2012 | K121458 | SPEEDICATH COMPACT SET (12/18 FR) Coloplast A/S | GBM |
| Jul 16, 2012 | K121833 | OSTOMY IRRIGATION SET Coloplast A/S | EXD |
| Jun 8, 2012 | K112860 | PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER Coloplast A/S | KNT |
| May 23, 2012 | K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX Coloplast A/S | NEW |
| May 17, 2012 | K112322 | RESTORELLE POLYPROPYLENE Y MESH Coloplast A/S | OTO |
| Apr 5, 2012 | K120828 | BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES Coloplast A/S | FRO |
| Feb 14, 2012 | K113496 | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT Coloplast A/S | OTM |
| Aug 17, 2011 | K111881 | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT Coloplast A/S | OTM |
| Jun 24, 2011 | K111233 | SUPRIS RETROPUBIC SLING SYSTEM Coloplast A/S | OTN |
| Jan 31, 2011 | K103254 | PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE Coloplast A/S | KNT |
| Dec 22, 2010 | K103568 | RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH Coloplast A/S | FTL |
| Oct 18, 2010 | K102485 | RE-TRACE URETERAL ACCESS SHEATH Coloplast A/S | FED |
| Jun 3, 2010 | K101297 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 Coloplast A/S | OTM |
| Feb 17, 2010 | K100218 | BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM Coloplast A/S | FRO |
| Nov 23, 2009 | K083770 | COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM Coloplast A/S | KNT |
| May 8, 2009 | K083499 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS Coloplast A/S | OTP |
| May 7, 2009 | K091152 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 Coloplast A/S, DK | OTM |
| Apr 23, 2009 | K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 Coloplast A/S | FBK |
| Sep 29, 1995 | K953497 | COMFEEL:ALGINATE DRESSING Coloplast A/S | KMF |
| Feb 13, 1995 | K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER Coloplast A/S | EXJ |
| Mar 16, 1993 | K925376 | COMFEEL(R) WOUND DRESSING SD Coloplast A/S | KMF |
| Oct 30, 1992 | K924406 | CONVEEN(R) LEG BAG(500 ML) Coloplast A/S | FAQ |
| Sep 23, 1992 | K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH Coloplast A/S | EXJ |
| Aug 17, 1992 | K922466 | COMFEEL WOUND DRESSING SD Coloplast A/S | KMF |
| Aug 17, 1992 | K922461 | COMFEEL WOUND DRESSING ORD Coloplast A/S | KMF |
| May 28, 1992 | K920925 | COMFEEL CONTOUR DRESSING Coloplast A/S | KMF |
| Feb 5, 1992 | K915246 | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) Coloplast A/S | EXI |
| Oct 31, 1990 | K904085 | ELLA BREAST FORM Coloplast A/S | KCZ |
| Oct 2, 1990 | K904086 | DISCRENE SELF-SUPPORTING BREAST FORM Coloplast A/S | KCZ |
| Feb 9, 1990 | K895548 | CONVEEN INTERMITTENT CATHETERS Coloplast A/S | KOD |
| Sep 26, 1989 | K894916 | COMFEEL TRANSPARENT DRESSING Coloplast A/S | KGX |
| Sep 22, 1988 | K883588 | COMPEED ATHLETIC DRESSING Coloplast A/S | FRO |
| Jul 13, 1988 | K881636 | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) Coloplast A/S | EXB |
| Nov 17, 1987 | K873669 | COMFEEL ULCUS ULCER CARE SYSTEM Coloplast A/S | FRO |
Newest 50 of 72.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||