Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

54 results for "Coloplast Corp."
1–24 of 54
Cleared Oct 06, 2025
Heylo™ System
K252140 · EXB
Coloplast Corp.
Gastroenterology & Urology · 90d
Cleared Jun 27, 2025
Luja Coudé
K251116 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d
Cleared Apr 17, 2025
Luja Set
K250270 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d
Cleared Nov 26, 2024
SureCath Set
K242049 · EZD
Coloplast Corp.
Gastroenterology & Urology · 137d
Cleared Nov 21, 2024
Luja Coude
K241210 · EZD
Coloplast Corp.
Gastroenterology & Urology · 205d
Cleared Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10,...
K242173 · FED
Coloplast Corp.
Gastroenterology & Urology · 111d
Cleared Oct 18, 2024
Altis Single Incision Sling System (519650)
K242473 · PAH
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Apr 15, 2024
Folysil Silicone Catheter
K233411 · EZL
Coloplast Corp.
Gastroenterology & Urology · 192d
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953 · FRO
Coloplast Corp.
General & Plastic Surgery · 266d
Cleared Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
K233101 · EZD
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone...
K213185 · FAD
Coloplast Corp.
Gastroenterology & Urology · 252d
Cleared Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy...
K211911 · LJE
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Feb 16, 2022
NovoFlow Reinforced Ureteral Stent
K213186 · FAD
Coloplast Corp.
Gastroenterology & Urology · 140d
Cleared Feb 25, 2021
Vortek Single Loop Ureteral Stent
K201436 · FAD
Coloplast Corp.
Gastroenterology & Urology · 269d
Cleared Dec 17, 2020
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · LJE
Coloplast Corp.
Gastroenterology & Urology · 230d
Cleared Jun 11, 2020
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · EZN
Coloplast Corp.
Gastroenterology & Urology · 55d
Cleared Dec 10, 2018
SabreLine and SabreGuard Laser Fibers
K182831 · GEX
Coloplast Corp.
General & Plastic Surgery · 62d
Cleared Nov 06, 2018
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469 · FAD
Coloplast Corp.
Gastroenterology & Urology · 258d
Cleared Oct 04, 2018
Ureteric Catheters
K182122 · EYB
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Mar 09, 2018
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · FAD
Coloplast Corp.
Gastroenterology & Urology · 60d
Cleared Dec 21, 2017
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated...
K171043 · EYB
Coloplast Corp.
Gastroenterology & Urology · 258d
Cleared Nov 15, 2017
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
K170362 · FAD
Coloplast Corp.
Gastroenterology & Urology · 282d
Cleared Nov 02, 2017
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
K170422 · FAD
Coloplast Corp.
Gastroenterology & Urology · 262d
Cleared Aug 17, 2017
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · EZN
Coloplast Corp.
Gastroenterology & Urology · 176d