510(k) Report

FDA applicant

Silverleaf Technologies, Inc.

Ottawa, Ontario, CA1 decision2003–20030 recalls

FDA records 1 decision for Silverleaf Technologies, Inc. (Ottawa, Ontario, CA) in 2003: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Silverleaf Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Silverleaf Technologies, Inc.’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 “Silverleaf”

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