FDA applicant

Andromeda Medizinische Systeme GmbH

Potomac, MD1 decision1997–19970 recalls

FDA records 1 decision for Andromeda Medizinische Systeme GmbH (Potomac, MD) in 1997: 1 510(k) clearance. All are in product code FEN (Device, Cystometric, Hydraulic). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Andromeda Medizinische Systeme GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andromeda Medizinische Systeme GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Andromeda Medizinische Systeme GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Andromeda Medizinische Systeme GmbH’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 “Andromeda”

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

Andromeda Research, Inc. 1

Andromeda Medizinische Systeme GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Andromeda”