Medical device database

Medical device database. Find information about medical devices cleared, approved, or regulated by the FDA. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Learn More Recalls A recall is an action taken to address a problem with a medical device that violates FDA law. Aug 26, 2024 · This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. 3 days ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Mar 5, 2021 · Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. more: Search Medical Device Databases. Dec 16, 2022 · Medical Devices - EUDAMED. , electromechanical), an exact phrase (e. Regulatory changes for software based medical devices; Reclassification of active medical devices for therapy with a diagnostic function What is a Medical Device Recall? Recalls Database; MedWatch: The FDA Safety Information and Adverse Event Reporting Program; Content current as of: 01/26/2023. 2 days ago · This database contains the classified Medical Device Recalls since november 1, 2002. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). We would like to show you a description here but the site won’t allow us. The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. Currently 225,738 medical devices and 35,430 manufacturers covered, with hundreds of new devices added monthly. 510(k) Premarket Notification Database. Establishment Registration and Medical Device Listing Files for Download. 5 days ago · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. - from manufacturing through distribution to patient use. . They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness Databases. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. Releasable establishment registration and listing information under the Aug 26, 2024 · Devices@FDA is a catalog of cleared and approved medical device information from fda. commercial medical device platform. You can use AccessGUDID to search for specific medical devices or download all the GUDID data at once. The FDA maintains several publicly accessible databases that may be of particular interest to sponsors and manufacturers of neurological devices including:. Search by device name, code, manufacturer, or other criteria in various databases, such as 510 (k)s, PMAs, MAUDE, GUDID, and more. The easiest way to find the newest medical devices and their manufacturers. The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… 3 days ago · Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. to search, enter a single word (e. Device Registration and Listing Database. An Action Plan for Medical Devices; Medical device reforms. Search Medical Device Databases. are required to register annually with the FDA. to search by product name, class, date initiated, reason for recall or recalling manufacturer select go to advanced search button. , electromechanical and infusion). With in-depth analysis, exclusive news, and highly detailed databases at your fingertips, we give you complete 360° insight into the medical device We cover the entire spectrum of the medical device industry – from suppliers, manufacturers and the distribution channel, all the way through to product insights and trends across the globe. Product classification; 510k Premarket 5 days ago · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. The FDB Prizm medical device database delivers medical device attributes from a variety of sources, such as FDA, GUDID, manufacturers, industry data pools, and more. Search the Registration & Listing database. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track Dec 27, 2018 · Health Canada’s drug and medical device databases are intended to increase transparency and to make information accessible to stakeholders and the general public. Aug 26, 2024 · Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. g. Jun 24, 2021 · The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). Nov 29, 2023 · Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U. , electromechanical pump) or multiple words connected by and (e. Although some information on drugs and medical devices can be accessed via alternate channels, Health Canada encourages stakeholders to use the databases as a primary means of We cover the entire spectrum of the medical device industry – from suppliers, manufacturers and the distribution channel, all the way through to product insights and trends across the globe. it includes links to the device summary information, manufacturer, approval date, user instructions, and AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, Global Medical Device MDR Database Search. Reports older than ten years are provided on the FDA's MDR Data Files webpage. Reports older than ten years are provided on the FDA's MDR Data Files 32 webpage. The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate (Compliance and Enforcement) through Establishment Licensing. With in-depth analysis, exclusive news, and highly detailed databases at your fingertips, we give you complete 360° insight into the medical device Medical device cyber security information for users; Medical device cyber security - Consumer information; Action plan for medical devices. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. It includes information pulled from CDRH databases including Premarket Approvals Aug 21, 2023 · The FDA is establishing the unique device identification system to adequately identify devices sold in the U. Product Code Classification Database. Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. S. Regulated Product(s) Oct 5, 2023 · 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 classification 3 days ago · This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. This Medical devices are products or equipment intended for a medical purpose. 3 days ago · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. A search query will produce information from the database in the following format: In addition, the following fact databases are available to the public for general search within the DMIDS (public part): Medical Devices Notifications (MPA), In Vitro Diagnostic Medical Devices Notifications (MPIVDA) and address databases with addresses of the persons reporting and of the competent authorities. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. The most user-friendly search engine of the US FDA medical device database. CDRH maintains searchable databases on its website containing 510(k) and PMA information. Within the context of a robust health system they ensure access to safe, effective, and high-quality medical devices that prevent, diagnose, and treat disease and injury, and assist patients in their rehabilitation. Releasable establishment registration and listing information under the Aug 26, 2024 · This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration 3 days ago · Devices@FDA is a catalog of cleared and approved medical device information from fda. Aug 26, 2024 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Aug 21, 2023 · The FDA is establishing the unique device identification system to adequately identify devices sold in the U. Medical device knowledge is standardized, normalized, and categorized by FDB data experts and structured to power your information system to deliver numerous possibilities to your International Medical Devices Database By the International Consortium of Investigative Journalists. hsszdbbj lrw vdgv cnww nwgaq jsauby hvqh mgyucwm jjfia cqh