510(k) Report

FDA applicant

Karlin Technology, Inc.

Marina Del Rey, CA17 decisions1988–19900 recalls

FDA records 17 decisions for Karlin Technology, Inc. (Marina Del Rey, CA) from 1988 to 1990: 17 510(k) clearances. Most are in product codes GAD (Retractor) and LXH (Orthopedic Manual Surgical Instrument). 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Karlin Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Karlin Technology, 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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