FDA applicant

Greiner Vacuette North America, Inc.

Baldwin, MD5 decisions2000–20022 recalls

FDA records 5 decisions for Greiner Vacuette North America, Inc. (Baldwin, MD) from 2000 to 2002: 5 510(k) clearances. Most are in product codes PJE (Blood/Plasma Collection Device For Dna Testing) and FMI (Needle, Hypodermic, Single Lumen). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

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

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Greiner Vacuette North America, 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 “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 America, Inc. 7 Greiner Bio-One Vacuette North America 5 Greiner Bio-One Na, Inc. 5

Greiner Vacuette North 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”