FDA applicant

Greiner America, Inc.

Lake Mary, FL7 decisions1996–199719 recalls

FDA records 7 decisions for Greiner America, Inc. (Lake Mary, FL) from 1996 to 1997: 7 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and GIM (Tubes, Vacuum Sample, With Anticoagulant). Its devices cite 3 predicates, 0 of them its own earlier devices. 19 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 America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2026

2007high 4 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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

Greiner America, 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”