Coloplast A/S
Coloplast A/S holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2026.
Name variants for Coloplast A/S
as filed with FDA- Coloplast A/S
- Coloplast A.S.
Top product codes for Coloplast A/S
Recent clearances by Coloplast A/S
- K262045 — Luja Soft
- K221874 — Altis Single Incision Sling System
- K220420 — Saffron Fixation System
- K191536 — Biatain Silicone Ag
- K181811 — ReTrace Ureteral Access Sheath
- K173527 — Digitex Delivery Device
- K140310 — Peristeen Anal Irrigation System
- K150935 — SpeediCath Compact Eve
- K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
- K143182 — Speedicath Compact Male
- K140523 — RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
- K140116 — RESTORELLE Y CONTOUR MESH
- K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
- K123914 — RESTORELLE Y CONTOUR
- K123675 — RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
- K121562 — ALTIS SINGLE INCISION CLING SYSTEM
- K121458 — SPEEDICATH COMPACT SET (12/18 FR)
- K121833 — OSTOMY IRRIGATION SET
- K112860 — PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
- K120284 — DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
- K112322 — RESTORELLE POLYPROPYLENE Y MESH
- K120828 — BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
- K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
- K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
- K111233 — SUPRIS RETROPUBIC SLING SYSTEM
- K103254 — PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
- K103568 — RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
- K102485 — RE-TRACE URETERAL ACCESS SHEATH
- K101297 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
- K100218 — BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
- K083770 — COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
- K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
- K091152 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
- K090217 — BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
- K953497 — COMFEEL:ALGINATE DRESSING
- K946243 — CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
- K925376 — COMFEEL(R) WOUND DRESSING SD
- K924406 — CONVEEN(R) LEG BAG(500 ML)
- K924407 — CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
- K922461 — COMFEEL WOUND DRESSING ORD
- K922466 — COMFEEL WOUND DRESSING SD
- K920925 — COMFEEL CONTOUR DRESSING
- K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
- K904085 — ELLA BREAST FORM
- K904086 — DISCRENE SELF-SUPPORTING BREAST FORM
- K895548 — CONVEEN INTERMITTENT CATHETERS
- K894916 — COMFEEL TRANSPARENT DRESSING
- K883588 — COMPEED ATHLETIC DRESSING
- K881636 — CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
- K873669 — COMFEEL ULCUS ULCER CARE SYSTEM
- K871610 — CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
- K871643 — CONVEEN(R) LEG-BAG (600 ML)
- K863830 — CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
- K861070 — COLOPLAST CONVEX RING
- K854580 — CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
- K844684 — COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
- K844685 — COLOPLAST URO 2002 UROSTOMY SYSTEM
- K834343 — COMFEEL POWDER
- K840362 — COMFEEL PASTE
- K840438 — COMFEEL ULCUS SHEET
- K833567 — COMFEEL PROTECTIVE FILM
- K840268 — IRRIGATION SYSTEM
- K840265 — MC 2002 OSTOMY POUCHES & SKIN FLANGES
- K840267 — FILTRODER FILTERS
- K840269 — MC 2000 OSTOMY POUCHES
- K833565 — COMFEEL PASTE
- K833570 — COLOPLAST BABY URINE COLLECTORS
- K833571 — STERILE DRAINAGE SYSTEM
- K840266 — K-FLEX OSTOMY POUCH
- K833566 — COMFEEL CLEANSER
- K833569 — COMFEEL BARRIER CREAM
- K832908 — COMFEEL PROTECTIVE RINGS
Data sourced from openFDA. This site is unofficial and independent of the FDA.