FDA applicant

Challenge Mfg., Inc.

Bend, OR4 decisions1988–19910 recalls

FDA records 4 decisions for Challenge Mfg., Inc. (Bend, OR) from 1988 to 1991: 4 510(k) clearances. Most are in product codes HDB (Extractor, Vacuum, Fetal) and HIS (Condom). 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 Challenge Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Challenge Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Challenge Mfg., 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 “Challenge”

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

Challenge Products, Inc. 4

Challenge Mfg., 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?

Other applicant names beginning “Challenge”