510(k) Report

FDA applicant

Medtech Products, Inc.

Tarrytown, NY14 decisions1985–20240 recalls

FDA records 14 decisions for Medtech Products, Inc. (Tarrytown, NY) from 1985 to 2024: 14 510(k) clearances. Most are in product codes HIS (Condom) and GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medtech Products , Ltd.”.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2024

2007: 12016: 12017: 22018: 12020: 12024: 1
2007high 2 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Medtech”

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