FDA applicant

Scimed

Maple Grove, MN8 decisions1990–19991 recall

FDA records 8 decisions for Scimed (Maple Grove, MN) from 1990 to 1999: 8 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQX (Wire, Guide, Catheter). 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Scimed since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Scimed”

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

Scimed Life Systems, Inc. 111 Scimed Peripheral Interventions 8

Scimed

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?

What has been recalled?

Other applicant names beginning “Scimed”