FDA applicant

Definitive Medical Technologies, Ltd.

Lod, IL1 decision2007–20075 recalls

FDA records 1 decision for Definitive Medical Technologies, Ltd. (Lod, IL) in 2007: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). Its devices cite 3 predicates, 0 of them its own earlier devices. 5 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 Definitive Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Definitive Medical Technologies, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Definitive Medical Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Definitive”

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

Definitive Diagnostics, Inc. 2

Definitive Medical Technologies, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Definitive”