FDA applicant

Baxter/ Synovis Micro Companies Alliance, Inc.

St. Paul, MN2 decisions2019–20193 recalls

FDA records 2 decisions for Baxter/ Synovis Micro Companies Alliance, Inc. (St. Paul, MN) in 2019: 2 510(k) clearances. All are in product code MVR (Device, Anastomotic, Microvascular). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Baxter/ Synovis Micro Companies Alliance, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2023

2019high 2 (2020) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Baxter/ Synovis Micro Companies Alliance, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baxter/ Synovis Micro Companies…’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 “Baxter/”

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

Baxter Healthcare Corp 574 Baxter Diagnostics, Inc. 72 Baxter Edwards 11 Baxter Bentley Laboratories, Inc. 3 Baxter Healthcare Corportation 3 Baxter Healthcare Corporation - Renal Division 2 Baxter Healthcare Corp/ Excel Medical 1 Baxter Centre For Medical Research 1 Baxter Healthcare Corproration 1 Baxter Corp. 1 Baxter Interwoven Offsite 1 Baxter Healthcare Corp., Bioscience 1

Baxter/ Synovis Micro Companies Alliance, 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 “Baxter/”