FDA applicant

Amedic USA

Phoenix, AZ10 decisions1987–19900 recalls

FDA records 10 decisions for Amedic USA (Phoenix, AZ) from 1987 to 1990: 10 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and HGL (Transducer, Ultrasonic, Obstetric). 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 Amedic USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amedic USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amedic USA 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 AB 1

Amedic USA

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Amedic”