FDA applicant

Abbott Mfg., Inc.

Abbott Park, IL14 decisions1990–199820 recalls

FDA records 14 decisions for Abbott Mfg., Inc. (Abbott Park, IL) from 1990 to 1998: 14 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and CFT (Radioimmunoassay, Prolactin (Lactogen)). Its devices cite 3 predicates, 0 of them its own earlier devices. 20 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 Abbott Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abbott Mfg., Inc. since 2007.

Recalls per year

1in 2013

2007high 2 (2009) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Abbott Mfg., 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 “Abbott”

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

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8 Abbott Ireland Diagnostics Division 8

Abbott Mfg., 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 “Abbott”