FDA applicant

Amedic AB

Sollentuna, SE1 decision1997–19970 recalls

FDA records 1 decision for Amedic AB (Sollentuna, SE) in 1997: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Amedic AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amedic 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 “Amedic”

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

Amedic USA 10

Amedic AB

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Amedic”