510(k) Report

FDA applicant

C.L. Mcintosh & Assoc., Inc.

Rockville, MD4 decisions1996–19970 recalls

FDA records 4 decisions for C.L. Mcintosh & Assoc., Inc. (Rockville, MD) from 1996 to 1997: 4 510(k) clearances. Most are in product codes JDX (Instrument, Surgical, Sonic And…) and IMI (Ultrasonic Diathermy For Use In Applying…). Its devices cite 3 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, orthopedic panel, where it files most

How often FDA has decided C.L. Mcintosh & Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for C.L. Mcintosh & Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — C.L. Mcintosh & Assoc., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C.L. Mcintosh & Assoc., 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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