FDA applicant

Medi-Tech, Inc.

Watertown, MA36 decisions1978–19968 recalls

FDA records 36 decisions for Medi-Tech, Inc. (Watertown, MA) from 1978 to 1996: 36 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and DTK (Filter, Intravascular, Cardiovascular). 8 recalls are linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Medi-Tech, Inc. since 2007.

Recalls per year

1in 2017

2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medi-Tech, 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 “Medi-Tech”

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

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-Source, Inc. 4

Medi-Tech, Inc.

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?

What has been recalled?

Other applicant names beginning “Medi-Tech”