FDA applicant

Scion Cardiovascular, Inc.

Miami, FL1 decision2000–20002 recalls

FDA records 1 decision for Scion Cardiovascular, Inc. (Miami, FL) in 2000: 1 510(k) clearance. All are in product code FGO (Dislodger, Stone, Flexible). 2 recalls are 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 Scion Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scion Cardiovascular, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Scion”

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

Scion Medical Technologies, LLC 6 Scion International, Inc. 4 Scion Cardio-Vascular, Inc. 4 Scion Valley, Inc. 1 Scion Neurostim, LLC 1

Scion Cardiovascular, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Scion”