Data / Medical devices / United States / Codonics, Inc.
Codonics, Inc.: FDA-registered device maker in Middleburg Heights, OH, United States, 4 510(k) clearances
Codonics, Inc. is registered with the FDA (registration 1530958) in Middleburg Heights, OH, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1530958
- FEI number
- 1000639866
- Address
- 17991 Englewood Dr, Middleburg Heights, OH, United States, 44130
- Owner or operator
- CODONICS, INC. (9026554)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- February 19, 1999
- Registered through
- 2026
- Brand names listed
- CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i/550i/600i, SLS-500P, SLS-XXX, Point of Care Station (PCS), Direct Vista Blue Blue Film,Direct Vista Blue-T(DVBT),Direct Vista Blue-5(DVB5), Direct Vista Clear,Direct Vista White Film,Chroma Vista White Film, Horizon Multimedia Imager Ci, Horizon Multimedia Imager G1, Horizon Multimedia Imager G2, Horizon Multimedia Imager GS, Horizon Multimedia Long Film XL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer, Remanufacturer | 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 11, 2025 | K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | BSZ | Substantially Equivalent | Codonics.Incorporated | accessdata.fda.gov |
| February 7, 2011 | K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | BSZ | Substantially Equivalent | Codonics, Inc. | accessdata.fda.gov |
| March 16, 2006 | K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER | LMC | Substantially Equivalent | Codonics, Inc. | accessdata.fda.gov |
| May 9, 2002 | K021054 | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER | LMC | Substantially Equivalent | Codonics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Colorimeter, Photometer, Spectrophotometer For Clinical Use
- All makers of Camera, Multi Format, Radiological
- All makers of Gas-Machine, Anesthesia
- All makers of Film, Radiographic
- All makers of System, Digital Image Communications, Radiological
- All makers of Device, Digital Image Storage, Radiological
Updated July 11, 2025. 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.