FDA applicant

Envision Advanced Medical System, Ltd.

Washington, DC1 decision2000–20000 recalls

FDA records 1 decision for Envision Advanced Medical System, Ltd. (Washington, DC) in 2000: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). 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 Envision Advanced Medical System, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Envision Advanced Medical System, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Envision Advanced Medical System, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Envision”

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

Envision Medical Corp. 5 Envision Surgical System, Inc. 3 Envision Endoscopy 2 Envision, Inc. 2

Envision Advanced Medical System, 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 “Envision”