FDA applicant

Level 1 Technologies, Inc.

Rockland, MA5 decisions1987–199611 recalls

FDA records 5 decisions for Level 1 Technologies, Inc. (Rockland, MA) from 1987 to 1996: 5 510(k) clearances. Most are in product codes LGZ (Warmer, Thermal, Infusion Fluid) and GCY (Apparatus, Suction, Single Patient Use…). 11 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 Level 1 Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Level 1 Technologies, Inc. since 2007.

Recalls per year

1in 2026

2007high 7 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Level 1 Technologies, 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 “Level”

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

Level-5, Inc. 1

Level 1 Technologies, 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 “Level”