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Over the past 29 years (1988 thru 2016), Daniel & Daniel Consulting, LLC has obtained clearance / approval for 100+ FDA submissions [e.g., IDE, Q-Sub, 513(g), 510(k) and PMA] for 20+ different device categories including IVDs, OBGYN, General Surgery, Cardiac Surgery, Cardiology, Gastroenterology, Neurology, and Vascular devices. Products have included: implantable, diagnostic, endoscopic, trans-oral, percutaneous, surgical, trans-cutaneous, software, disposable, and electro-mechanical 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.