FDA applicant

Getinge USA, Inc.

Rochester, NY4 decisions2003–20050 recalls

FDA records 4 decisions for Getinge USA, Inc. (Rochester, NY) from 2003 to 2005: 4 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and JOJ (Indicator, Physical/Chemical Sterilization…). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Getinge USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Getinge USA, 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 “Getinge”

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

Getinge/Castle, Inc. 9 Getinge Sourcing, LLC 7 Getinge International, Inc. 4 Getinge (Suzhou) Co., Ltd. 2 Getinge Disinfection, Inc. 1

Getinge USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Getinge”