FDA applicant

Medix I.C.S.A.

Houston, TX6 decisions1993–20112 recalls

FDA records 6 decisions for Medix I.C.S.A. (Houston, TX) from 1993 to 2011: 6 510(k) clearances. Most are in product codes LBI (Unit, Neonatal Phototherapy) and FMZ (Incubator, Neonatal). Its devices cite 5 predicates, 2 of them its own earlier devices. 2 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 hospital panel, where it files most

How often FDA has decided Medix I.C.S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medix I.C.S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medix I.C.S.A.’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 “Medix”

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

Medix Biotech, Inc. 39 Medix Medical Electronics (U.S.A.), Inc. 14 Medix Corp. 6 Medix Biochemica 1 Medix of Florida, Inc. 1 Medix Pharmaceuticals Americas, Inc. 1

Medix I.C.S.A.

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 “Medix”