510(k) Report

FDA applicant

Quali-Med, Inc.

Sugar Land, TX7 decisions1986–19870 recalls

FDA records 7 decisions for Quali-Med, Inc. (Sugar Land, TX) from 1986 to 1987: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FRG (Wrap, Sterilization). 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 Quali-Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quali-Med, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Quali-Med, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report