510(k) Report

FDA applicant

Evera Medical, Inc.

Foster City, CA2 decisions2007–20090 recalls

FDA records 2 decisions for Evera Medical, Inc. (Foster City, CA) from 2007 to 2009: 2 510(k) clearances. Most are in product codes HPZ (Implant, Eye Sphere) and FTL (Mesh, Surgical, Polymeric). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Evera Medical, 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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