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Surgical Info Sciences 510(k) for Brain Visualization

[ Price : $8.95]

FDA clears a Surgical Information Sciences 510(k) for an updated algorithm with new visualization capabilities for its SIS System.

Orthofix 3D Spinal Implant Cleared

[ Price : $8.95]

FDA clears an Orthofix Medical 510(k) for its 3D-printed Construx Mini Ti Spacer System for use in enhancing anterior cervical dis...

Device Group Report on Patient Input

[ Price : $8.95]

The Medical Device Innovation Consortium releases a new report entitled Maximizing Patient Input in the Design and Development of ...

NCTR Science Board Meeting 5/11-12

[ Price : $8.95]

Federal Register notice: FDA announces a 5/11-12 Science Advisory Board to the National Center for Toxicological Research advisory...

Info Collection Extension on Device Recall Authority

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CF...

FDA Complete Response on Nuplazid sNDA

[ Price : $8.95]

FDA sends Acadia Pharmaceuticals a complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallu...

Latest Federal Register Notices

[ Price : $8.95]

FDA Review posts the Federal Register notices for the week ending 4/2/2020.

FDA Revokes EUA for Respirator Decontaminator

[ Price : $8.95]

Federal Register notice: FDA announces an Emergency Use Authorization revocation of NovaSterilis Nova2200 using the NovaClean deco...

Empirical Spine Breakthrough for Spinal Tension Band

[ Price : $8.95]

FDA grants Empirical Spine a breakthrough device designation for its LimiFlex Paraspinous Tension Band and its use in spinal surge...

Regulatory Review Determined for Ardelyxs Ibsrela

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ardelyxs Ibsrela (tenapanor...