FDA applicant

Xeridiem (Formerly Mri)

Tucson, AZ2 decisions2015–2015104 recalls

FDA records 2 decisions for Xeridiem (Formerly Mri) (Tucson, AZ) in 2015: 2 510(k) clearances. All are in product code PIF (Gastrointestinal Tubes With Enteral Specific…). Its devices cite 3 predicates, 0 of them its own earlier devices. 104 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, gastroenterology and urology panel, where it files most

How often FDA has decided Xeridiem (Formerly Mri)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

104in 2015

2015high 104 (2015) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Xeridiem (Formerly Mri) by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xeridiem (Formerly Mri)’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 “Xeridiem”

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

Xeridiem Medical Devices 3 Xeridiem Medical Devices, A Spectrum Plastics Group… 2

Xeridiem (Formerly Mri)

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 “Xeridiem”