FDA applicant

Swemed Laboratories, Inc.

Sweden, SE2 decisions1986–19860 recalls

FDA records 2 decisions for Swemed Laboratories, Inc. (Sweden, SE) in 1986: 2 510(k) clearances. Most are in product codes HEM (Imager, Ultrasonic Obstetric-Gynecologic) and HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). 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 Swemed Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Swemed Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Swemed Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Swemed”

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

Swemed Lab International AB 4 Swemed Lab Intl. 1

Swemed Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Swemed”