Coloplast Corp.
United StatesFDA applicant, unverified
Coloplast Corp. is a medical device manufacturer, with 77 devices listed in FDA 510(k), FDA GUDID and FDA PMA (FDA Class II, Class I, Unclassified and Class III) and 3 FDA recalls as of 13 Nov 2026.
- Devices
- 77
- FDA recalls
- 3
Registry facts
- Registries
- FDA 510(k) 69
- FDA GUDID 5
- FDA PMA 3
- Device classes
- FDA Class II 44
- FDA Class I 18
- FDA Unclassified 11
- FDA Class III 4
- FDA recalls
- Identifiers
- DUNS 847436391
At a glance
Market reach
- United States
- FDA recalls
What Coloplast Corp. makes
The company manufactures reusable antimicrobial fabrics for skin friction and moisture control, incontinence liners, and guidewire holders. It produces urological stents, prolapse repair systems, and breast forms for medical or clinical use. Additional products include dressings with silver-infused fibers for wound care, insertion tools for medical devices, and incontinence management solutions like absorbent pants liners.
The portfolio includes devices classified as Class I, Class II, Class III, and unclassified (U) under FDA regulations. Products are authorised via 510(k) clearances, PMA approvals, and UDI listings in the FDA registry.
Catalogue
Search and filter all 77 devicesShowing 1-50 of 77
Company details
- DUNS number
- 847436391
- Phone
- +1(800)258-3476
FDA recalls
FDA recall records list 3 recalls initiated by Coloplast Corp., initiated on 2007-11-12. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 12 Nov 2007 Z-0713-2008 Unclassified (pre-2012) Terminated Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
- 12 Nov 2007 Z-0714-2008 Unclassified (pre-2012) Terminated Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
- 12 Nov 2007 Z-0715-2008 Unclassified (pre-2012) Terminated Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
Frequently asked questions
How many devices does Coloplast Corp. have in the registry?
The registry currently lists 77 devices for Coloplast Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coloplast Corp.'s devices?
Among its 50 most recently registered devices, Coloplast Corp. has devices listed in FDA 510(k) (45 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Coloplast Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Coloplast Corp.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Coloplast Corp.?
FDA recall records list 3 recalls initiated by Coloplast Corp., the most recent initiated on 12 Nov 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Coloplast Corp. in the registry?
The most recently registered devices listed for Coloplast Corp. include Manhood 27-4200-B / 50710, InterDry 7915, InterDry 7910 and InterDry 7912.