Coloplast

FDA Filings

This page includes the latest FDA filings for Coloplast. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Coloplast holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Sterigenics SAS

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K221401 Coloplast	Self-Cath And Self-Cath Plus	2022-12-02
PMN K222059 Coloplast	SpeediCath Flex Set	2022-09-21
PMN K200142 Coloplast	SpeediCath Soft	2020-07-30
PMN K190620 Coloplast	SpeediCath Flex Coude Pro	2019-07-10
PMN K180258 Coloplast	SpeediCath Standard	2018-10-25
PMN K173501 Coloplast	Meridian Vaginal Positioning System (VPS)	2018-02-09
PMN K180070 Coloplast	SpeediCath Flex Coude Pro	2018-02-02

Similar & Related FDA Registered Companies

COLOPLAST CORP.
Coloplast A/S
COLOPLAST MANUFACTURING US, LLC
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS065 Date Received12/16/2022 Decision Date01/12/2023 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS063 Date Received11/02/2022 Decision Date12/01/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS011 Date Received08/17/2022 Decision Date09/16/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS062 Date Received07/27/2022 Decision Date08/24/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS010 Date Received07/27/2022 Decision Date08/24/2022 Product Code FAF Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS061 Date Received03/16/2022 Decision Date04/15/2022 Product Code FHW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080167558	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	18 PKG
2020072869570	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	18 PKG
2020070782374	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	63 PKG
2020070782374	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	63 PKG
2020070782374	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	63 PKG
2020070782374	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	63 PKG
2020062558944	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020062558944	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020062558944	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020062469601	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020062469601	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020062469601	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	45 PKG
2020052056507	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	27 PKG
2020052056507	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTER	27 PKG
2019102435567	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	PLASTERS	6 PKG
2019102252874	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	PLASTERS	6 PKG