FDA applicant

Baxter Bio Science

Round Lake,1 decision2003–20036 recalls

FDA records 1 decision for Baxter Bio Science (Round Lake,) in 2003: 1 original PMA approval. All are in product code NBE (Sealant, Polymerizing). 6 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, cardiovascular panel, where it files most

How often FDA has decided Baxter Bio Science’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baxter Bio Science since 2007.

Recalls per year

1in 2023

2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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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/ Synovis Micro Companies Alliance, Inc. 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 Bio Science

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Baxter”