FDA applicant

Core Dynamics, Inc.

Jacksonville, FL23 decisions1990–19997 recalls

FDA records 23 decisions for Core Dynamics, Inc. (Jacksonville, FL) from 1990 to 1999: 23 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HET (Laparoscope, Gynecologic (And Accessories)). 7 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, gastroenterology and urology panel, where it files most

How often FDA has decided Core Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

7in 2016

2007high 7 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Core Dynamics, 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

Other applicant names beginning “Core”

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

Core-Vent Corp. 25 Core Essence Orthopaedics, LLC 6 Core-M, Inc. 4 Core Medical, Inc. 3 Core-Nexus 2 Core-Vent Bio-Engineering, Inc. 1 Core 3D Protech, S.L. 1 Core Healthcare, Ltd. 1 Core Access Surgical Technologies, Inc. 1 Core Scientific, Ltd. 1 Core Scientific Creation, Ltd. 1

Core Dynamics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Core”