FDA applicant

Mast Biosurgery USA, Inc.

San Diego, CA4 decisions2005–20101 recall

FDA records 4 decisions for Mast Biosurgery USA, Inc. (San Diego, CA) from 2005 to 2010: 4 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 16 predicates, 2 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Mast Biosurgery USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mast Biosurgery USA, Inc.’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 “Mast”

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

Mast Immunosystems 13 Mast Biosurgery 2 Mast Group, Ltd. 1

Mast Biosurgery USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

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 “Mast”