510(k) Report

FDA applicant

Tecnol New Jersey Wound Care, Inc.

Fort Worth, TX35 decisions1976–19912 recalls

FDA records 35 decisions for Tecnol New Jersey Wound Care, Inc. (Fort Worth, TX) from 1976 to 1991: 35 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FXP (Cover, Shoe, Operating-Room). 2 recalls are 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 Tecnol New Jersey Wound Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tecnol New Jersey Wound Care, Inc. since 2007.

Recalls per year

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tecnol New Jersey Wound Care, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tecnol New Jersey Wound Care, 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 “Tecnol”

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