FDA applicant

Telemed Systems, Inc.

Hudson, MA22 decisions1990–20022 recalls

FDA records 22 decisions for Telemed Systems, Inc. (Hudson, MA) from 1990 to 2002: 22 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and FDX (Endoscopic Cytology Brush). Its devices cite 1 predicate, 1 of them its own earlier devices. 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Telemed Systems, Inc. since 2007.

Recalls per year

2in 2021

2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Telemed Systems, 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 “Telemed”

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

Telemed 5 Telemed Div. 2 Telemed Solutions, Inc. 1

Telemed Systems, 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 “Telemed”