FDA applicant

Aspen Medical, Ltd.

Scotland, GB1 decision1992–19920 recalls

FDA records 1 decision for Aspen Medical, Ltd. (Scotland, GB) in 1992: 1 510(k) clearance. All are in product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…). 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 Aspen Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aspen Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aspen Medical, 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 “Aspen”

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

Aspen Laboratories, Inc. 55 Aspen Labs 6 Aspen Glove Sdn. Bhd. 4 Aspen Surgical Products, Inc. 2 Aspen Laser Systems, LLC 2 Aspen Imaging Healthcare, Inc. 2

Aspen Medical, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Aspen”