FDA applicant

Deltec Systems, Inc.

St. Paul, MN9 decisions1984–198718 recalls

FDA records 9 decisions for Deltec Systems, Inc. (St. Paul, MN) from 1984 to 1987: 9 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DYB (Introducer, Catheter). 18 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Deltec Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Deltec Systems, Inc. since 2007.

Recalls per year

4in 2017

2007high 6 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Deltec Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Deltec”

FDA records each applicant name separately; these may or may not be the same firm.

Deltec, Inc. 5

Deltec Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Deltec”