510(k) Report

FDA applicant

Heraeus, Inc.

West Conshohocken, PA1 decision1985–19850 recalls

FDA records 1 decision for Heraeus, Inc. (West Conshohocken, PA) in 1985: 1 510(k) clearance. No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Heraeus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Heraeus, 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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What has FDA decided for it lately?

  • K853460Endo L 300 Light, Illuminating Wound RectractorHeraeus, Inc. · 1985

The one decision as Heraeus, Inc. →

Other applicant names beginning “Heraeus”

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

Heraeus Kulzer, Inc. 170Heraeus Lasersonics, Inc. 38Heraeus Medical GmbH 13Heraeus Surgical, Inc. 8Heraeus Medical Components, LLC 4Heraeus Med GmbH 3Heraeus Dental Gold Corp. 3Heraeus-Christ GmbH 2Heraeus Kulzer, LLC (Mitsui Chemicals Group) 2Heraeus Medical GmbH Technology 1Heraeus Instruments GmbH 1Heraeus Kulzer, Inc., Dental Products Division 1