FDA applicant

Greiner Meditech, Inc.

Bel Air, MD10 decisions1997–19997 recalls

FDA records 10 decisions for Greiner Meditech, Inc. (Bel Air, MD) from 1997 to 1999: 10 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 7 predicates, 0 of them its own earlier devices. 7 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Greiner Meditech, Inc. since 2007.

Recalls per year

1in 2025

2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Greiner Meditech, Inc.’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 “Greiner”

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

Greiner Bio-One North America, Inc. 10 Greiner America, Inc. 7 Greiner Vacuette North America, Inc. 5 Greiner Bio-One Vacuette North America 5 Greiner Bio-One Na, Inc. 5

Greiner Meditech, 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 “Greiner”