510(k) Report

FDA applicant

Precise Medical Products, Ltd.

Shlomi, IL2 decisions2004–20062 recalls

FDA records 2 decisions for Precise Medical Products, Ltd. (Shlomi, IL) from 2004 to 2006: 2 510(k) clearances. All are in product code MEB (Pump, Infusion, Elastomeric). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Precise Medical Products”.

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 Precise Medical Products, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precise Medical Products, Ltd. since 2007.

Recalls per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Precise Medical Products, 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 “Precise”

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