FDA applicant

Eagle Twe, Inc.

Tucker, GA5 decisions2001–20050 recalls

FDA records 5 decisions for Eagle Twe, Inc. (Tucker, GA) from 2001 to 2005: 5 510(k) clearances. All are in product code HIS (Condom). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Eagle Twe, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eagle Twe, 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 “Eagle”

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

Eagle Vision, Inc. 7 Eagle Medical Equipment Co. 3 Eagle Medical, Inc. 3 Eagle Parts & Products, Inc. 2 Eagle Endoscopic, Inc. 2 Eagle Medical Intl. 1 Eagle Heart Imaging, LLC 1 Eagle Technology, Inc. 1 Eagle Health Supplies 1

Eagle Twe, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Eagle”