FDA applicant

Biocare Corp.

Taoyuan, TW4 decisions2000–20130 recalls

FDA records 4 decisions for Biocare Corp. (Taoyuan, TW) from 2000 to 2013: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and JGS (Electrode, Ion Specific, Sodium). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biocare Corporation”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Biocare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocare Corp.’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 “Biocare”

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

Biocare Asia Corporation, Ltd. 3 Biocare Systems, Inc. 2 Biocare Intl. 1 Biocare Bio-Medical Equipment Co., Ltd. 1

Biocare Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Biocare”