FDA applicant

Getinge International, Inc.

Lakewood, NJ4 decisions1982–19941 recall

FDA records 4 decisions for Getinge International, Inc. (Lakewood, NJ) from 1982 to 1994: 4 510(k) clearances. Most are in product codes MDZ (Cleaners, Medical Devices) and FLE (Sterilizer, Steam). 1 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 International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Getinge International, 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 USA, Inc. 4 Getinge (Suzhou) Co., Ltd. 2 Getinge Disinfection, Inc. 1

Getinge International, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Getinge”