FDA applicant

Medsphere International, Inc.

Fremont, CA4 decisions2003–20040 recalls

FDA records 4 decisions for Medsphere International, Inc. (Fremont, CA) from 2003 to 2004: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Medsphere International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medsphere International, 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 “Medsphere”

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

Medsphere Technologies Pvt, Ltd. 1

Medsphere International, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medsphere”