FDA applicant

Aesculap-Meditec North America

Irvine, CA6 decisions1998–20000 recalls

FDA records 6 decisions for Aesculap-Meditec North America (Irvine, CA) from 1998 to 2000: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Aesculap-Meditec North America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aesculap-Meditec North America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aesculap-Meditec North America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aesculap-Meditec North America’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 “Aesculap-Meditec”

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

Aesculap, Inc. 219 Aesculap Implant Systems, LLC 51 Aesculap Implant System, Inc. 18 Aesculap Instruments Corp. 13 Aesculap Implants Systems, LLC 4 Aesculap-Meditec GmbH 3

Aesculap-Meditec North America

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?

Other applicant names beginning “Aesculap-Meditec”