Data / Medical devices / United States / Century Pharmaceuticals, Inc.
Century Pharmaceuticals, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 3 510(k) clearances
Century Pharmaceuticals, Inc. is registered with the FDA (registration 1819174) in Indianapolis, IN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 21, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1819174
- Address
- 10377 Hague RD, Indianapolis, IN, United States, 46256
- Owner or operator
- Century Pharmaceuticals, Inc. (1819174)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 24, 2008
- Registered through
- 2027
- Brand names listed
- Dakin's Wound Cleanser, Dakin's Wound Cleanser Pro, Moi-Stir
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 21, 2016 | K150208 | Dakin's Skin and Wound Cleanser | FRO | Substantially Equivalent | Century Pharmaceuticals, Inc. | accessdata.fda.gov |
| August 7, 2009 | K090791 | DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% | FRO | Substantially Equivalent | Century Pharmaceuticals, Inc. | accessdata.fda.gov |
| February 10, 1981 | K810157 | MOI-STIR | LFD | Substantially Equivalent | Kingswood Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 21, 2016. 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.