Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

56 results for "Coloplast Corp."
1–24 of 56
Search insights Median review: 89d Cleared: 100% Top manufacturer: Coloplast Corp. Lead specialty: Gastroenterology & Urology
Cleared Oct 28, 2026
Luja female
K263512 · EZD
Coloplast Corp.
Gastroenterology & Urology · 29d
Cleared Oct 26, 2026
Triad Hydrophilic Wound Dresssing (1964, 2.5 oz)
K260285 · FRO
Coloplast Corp.
General & Plastic Surgery · 270d
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