Data / Medical devices / Canada / Kimberly-Clark Inc.
Kimberly-Clark Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 2 510(k) clearances
Kimberly-Clark Inc. is registered with the FDA (registration 9710006) in Mississauga Ontario, Canada. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710006
- FEI number
- 1000312280
- Address
- 1200-50 Burnhamthorpe Road West, Mississauga Ontario, Canada, L5B 3Y5
- Owner or operator
- KIMBERLY-CLARK CORPORATION (9001775)
- Roles
- Exporter to the US
- First device listed
- April 5, 2001
- Registered through
- 2026
- Brand names listed
- Depend, Kotex, Poise, Speax, Thinx, Thinx Teen, U by Kotex, goodnites
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2023 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| October 11, 2017 | K172118 | U by Kotex Click Unscented Menstrual Tampons | HEB | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Reusable
- All makers of Pad, Menstrual, Unscented
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
Updated January 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.