FDA applicant
Quali-Med, Inc.
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
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.
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.
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