510(k) Report

FDA applicant

Medtek Devices, Inc.

Buffalo, NY2 decisions2006–20110 recalls

FDA records 2 decisions for Medtek Devices, Inc. (Buffalo, NY) from 2006 to 2011: 2 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FYD (Apparatus, Exhaust, Surgical). Its devices cite 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medtek Devices, 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 “Medtek”

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