Coloplast Corp.
Coloplast Corp. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2025.
Top product codes for Coloplast Corp.
Recent clearances by Coloplast Corp.
- K252140 — Heylo System
- K251116 — Luja Coudé
- K250270 — Luja Set
- K242049 — SureCath Set
- K241210 — Luja Coude
- K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
- K242473 — Altis Single Incision Sling System (519650) +2 more
- K233411 — Folysil Silicone Catheter
- K231953 — Biatain Fiber Ag (5 models)
- K233101 — Luja Coude (20108 Male CH18 - large packaging)
- K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
- K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
- K213186 — NovoFlow Reinforced Ureteral Stent
- K201436 — Vortek Single Loop Ureteral Stent
- K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K182831 — SabreLine and SabreGuard Laser Fibers
- K180469 — ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
- K182122 — Ureteric Catheters
- K180057 — VORTEK URETERAL DOUBLE LOOP STENT
- K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
- K170362 — VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
- K170422 — BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
- K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators
- K161672 — SpeediCath Flex Coude
- K132061 — RESTORELLE M, RESTORELLE XL
- K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
- K122440 — RESTORELLE L
- K121457 — SPEEDICATH COMPACT SET (12 FR)
- K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
- K072808 — SPEEDICATH COMPACT
- K052229 — COLOPLAST OSTOMY ROD, MODEL 12814
- K033869 — CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
- K022416 — CONTREET FOAM ADHESIVE/NON-ADHESIVE
- K023254 — SPEEDICATH
- K013525 — CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
- K991202 — MODIFICATION TO WOUN'DRES
- K982493 — COMPEED PSORIASIS DRESSING
- K983519 — COMFEEL SEASORB DRESSING
- K983163 — BIATAIN FOAM DRESSING
- K983173 — BIATAIN FOAM ADHESIVE DRESSING
- K983042 — SWEEN WOUN'DRES
- K973070 — CONVEEN EASICATH SET
- K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
- K955609 — CONVEEN URINE BAG - STERILE
- K954857 — COMFEEL:ALGINATE FILLER
- K953783 — CONVEEN LEG BAG STRAP
- K923351 — SKIN SUPPORT PREP PAD
- K921535 — SUOENA AFFINITY (TM) MODEL #802
- K915382 — AMOENA AFFINITY MODEL #802
- K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
- K864785 — AMOENA BREAST FORMS
- K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
- K853822 — AMOENA BREAST FORMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.