FDA applicant

Optimed Technologies, Inc.

Orange, CA15 decisions1988–19971 recall

FDA records 15 decisions for Optimed Technologies, Inc. (Orange, CA) from 1988 to 1997: 15 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and HIH (Hysteroscope (And Accessories)). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Optimed Technologies, Inc. since 2007.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Optimed 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 “Optimed”

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

Optimed, Inc. 4 Optimed Therapeutics 1

Optimed Technologies, 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 “Optimed”