FDA applicant

Waters Corporation

Milford, MA6 decisions1996–20070 recalls

FDA records 6 decisions for Waters Corporation (Milford, MA) from 1996 to 2007: 6 510(k) clearances. Most are in product codes MLM (Enzyme Immunoassay, Tracrolimus) and LDM (Instrumentation, High Pressure Liquid…). 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, clinical chemistry panel, where it files most

How often FDA has decided Waters Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Waters Corporation’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 “Waters”

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

Waters Assoc., Inc. 16 Waters Instruments, Inc. 12 Waters Medical Systems, LLC 3 Waters Chemical Products 2 Waters Chromatography Division 1

Waters Corporation

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Waters”