Over the past 20 years (1988 thru 2009), Daniel & Daniel Consulting has obtained clearance / approval for 50+ pre-market [510(k) and PMA] submissions for 20+ different device categories including IVDs, OBGYN, General Surgery, Cardiac Surgery, Caridology, Gastroenertology and Vascular devices. Products have included implantable, diagnostic, endoscopic, transoral, percutaneous, surgical, disposable and robotic devices.

Clearance / approval for many of these product lines required extensive clinical studies and IDE approvals with several resulting in FDA reversal of initial PMA classification. During the same period we obtained several Canadian Therapeutic Branch product line approvals as well as multiple CE Mark and Japanese Shonin product line approvals.