FDA applicant
Medical Dynamics, Inc.
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
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.
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.
See the 510(k) Report