510(k) Report

FDA applicant

Medical Dynamics, Inc.

Englewood, CO18 decisions1988–19980 recalls

FDA records 18 decisions for Medical Dynamics, Inc. (Englewood, CO) from 1988 to 1998: 18 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCB (Needle, Catheter). 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 Medical Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Dynamics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Dynamics, 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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