Codonics, Inc.
Middleburg Heights, OH, US
CODONICS, INC. appears in FDA device records in Middleburg Heights, OH. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Codonics, Inc. between 1996 and 2011. The busiest year on record is 1996, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | BSZ | Substantially Equivalent | |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER | LMC | Substantially Equivalent | |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | LMC | Substantially Equivalent | |
| K030690 | CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS | LMC | Substantially Equivalent | |
| K021054 | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER | LMC | Substantially Equivalent | |
| K003481 | CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 | LMC | Substantially Equivalent | |
| K962364 | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) | LMC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1530958 | 1000639866 | CODONICS, INC. | 17991 Englewood Dr, Middleburg Heights, OH 44130 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain