FDA applicant

Medrad, Inc. / Bayer Medical Care, Inc.

Indianola, PA2 decisions2013–20142 recalls

FDA records 2 decisions for Medrad, Inc. / Bayer Medical Care, Inc. (Indianola, PA) from 2013 to 2014: 2 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and FPK (Tubing, Fluid Delivery). Its devices cite 3 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Medrad, Inc. / Bayer Medical Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2021

2013high 1 (2015) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Medrad, Inc. / Bayer Medical Care, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medrad, Inc. / Bayer Medical Care, 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 “Medrad”

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

Medrad, Inc. 105 Medrad Interventional/Possis 2 Medrad/Technology For People 1

Medrad, Inc. / Bayer Medical Care, 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?

What has been recalled?

Other applicant names beginning “Medrad”