FDA applicant

Astra Meditec AB

Sweden, SE3 decisions1988–19930 recalls

FDA records 3 decisions for Astra Meditec AB (Sweden, SE) from 1988 to 1993: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and GCY (Apparatus, Suction, Single Patient Use…). 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, dental panel, where it files most

How often FDA has decided Astra Meditec AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Astra Meditec AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Astra”

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

Astra Tech, Inc. 38 Astra Pharmaceutical Products, Inc. 2 Astra Orthomed, Inc. 1

Astra Meditec AB

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 “Astra”