FDA applicant

Safersonic Medizinprodukte GmbH

Greenwood Village, CO1 decision2009–20090 recalls

FDA records 1 decision for Safersonic Medizinprodukte GmbH (Greenwood Village, CO) in 2009: 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 Safersonic Medizinprodukte GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Safersonic Medizinprodukte GmbH by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Safersonic”

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

Safersonic Us, Inc. 1

Safersonic Medizinprodukte GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Safersonic”