510(k) Report

FDA applicant

Vista Medical Technologies, Inc.

Westborough, MA9 decisions1995–20021 recall

FDA records 9 decisions for Vista Medical Technologies, Inc. (Westborough, MA) from 1995 to 2002: 9 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). Its devices cite 14 predicates, 6 of them its own earlier devices. 1 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 Vista Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vista Medical Technologies, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Vista Medical Technologies, 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 “Vista”

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