FDA applicant

Unicare Biomedical, Inc.

Laguna Hills, CA11 decisions1998–20150 recalls

FDA records 11 decisions for Unicare Biomedical, Inc. (Laguna Hills, CA) from 1998 to 2015: 11 510(k) clearances. Most are in product codes LYC (Bone Grafting Material, Synthetic) and OLR (Oral Wound Dressing). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Unicare Biomedical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

FDA decisions per year

1in 2015

2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Unicare Biomedical, 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 “Unicare”

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

Unicare Systems, Inc. 1 Unicare Medical Products, Inc. 1

Unicare Biomedical, 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?

Other applicant names beginning “Unicare”