FDA applicant

Medi-Tate, Ltd.

Hadera, IL2 decisions2020–20210 recalls

FDA records 2 decisions for Medi-Tate, Ltd. (Hadera, IL) from 2020 to 2021: 1 510(k) clearance and 1 De Novo grant. All are in product code QKA (Temporarily-Placed Urethral Opening System For…). Its devices cite 1 predicate, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Medi-Tate, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Medi-Tate, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Medi-Tate”

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

Medi-Tech, Inc. 36 Medi-Globe Corp. 26 Medi-Flex Hospital Products, Inc. 13 Medi-Plast Intl., Inc. 12 The Medi-Dose Group 10 Medi Nuclear Corp., Inc. 9 Medi-Physics Inc. Dba Nycomed Amersham Imaging 9 Medi-Craft, Ltd. 9 Medi-Spec 8 Medi-Man Rehabilitation Products, Inc. 4 Medi Tex, Inc. 4 Medi-Dose, Inc. 4

Medi-Tate, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medi-Tate”