FDA applicant

Safe Medical Design

San Francisco, CA1 decision2019–20190 recalls

FDA records 1 decision for Safe Medical Design (San Francisco, CA) in 2019: 1 510(k) clearance. All are in product code EZL (Catheter, Retention Type, Balloon). 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 Safe Medical Design’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Safe Medical Design by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safe Medical Design’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Safe”

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

Safe Orthopaedics 13 Safe Shield Co., Ltd. 2 Safe Tech Medical Products, Inc. 2 Safe-Tec Clinical Products, Inc. 2 Safe Secure Packaging Co., Ltd. 2 Safe Glove, Ltd. 2 Safe Obstetric Systems, Ltd. 1 Safe Product Supplies 1 Safe T Medical Devices, Ltd. 1 Safe Secure Packing Co., Ltd. 1 Safe Restraints, Inc. 1 Safe Sun Corporation of America, Inc. 1

Safe Medical Design

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?

Other applicant names beginning “Safe”