List of Medical Devices, by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA amending Section 519(f) of...

Devices@FDA is a catalog of cleared and approved medical device information from FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and...

2023年10月5日 · Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the...

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).

2021年2月24日 · As part of the National Strategy, the government sought to develop a Critical Medical Device List (CMDL) to help government, business, and healthcare leaders focus supply chain resilience resources on those devices where disruptions can lead to serious injury or death to patients or providers.

2025年2月3日 · a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Learn More...

List of Medical Devices, by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA amending Section 519(f) of the FDC Act November 2012

Medical devices are instruments, apparatuses, machines, or implants that are used for medical purposes. They are designed to diagnose, prevent, monitor, or treat diseases or medical conditions without exerting a primary chemical action within or …