Medical Device Manufacturer · US , Middleburg Heights , OH

Codonics.Incorporated

1 submissions · 1 cleared · Since 2025

Total

Cleared

Denied

Codonics.Incorporated — FDA 510(k) Submissions

Codonics.Incorporated has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gas-machine, Anesthesia . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

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)

K251352 · BSZ Gas-machine, Anesthesia · Anesthesiology

Jul 2025 72d

Codonics.Incorporated

Codonics.Incorporated — FDA 510(k) Submissions

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