FDA applicant

Heraeus Surgical, Inc.

Milpitas, CA8 decisions1994–19960 recalls

FDA records 8 decisions for Heraeus Surgical, Inc. (Milpitas, CA) from 1994 to 1996: 8 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GCJ (Laparoscope, General & Plastic Surgery). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Heraeus Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Heraeus Surgical, 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 “Heraeus”

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

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

Heraeus Surgical, Inc.

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 “Heraeus”