21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) 🇺🇸 A regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for writing Dear Doctor Letters for recalls of Implantable Cardioverter Defibrillators (ICDs). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-02049. The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled "Effective Date of Requirement for Premarket Approval for Automated External Defibrillator" that published in the Federal Register on January 29, 2015 (80 FR… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 3, 2015 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-01619. The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 29, 2015 Other (Public Domain) 0 reuses 0 favorites
Commission Delegated Directive 2014/13/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators Text with EEA relevance From European Parliament 🇪🇺 Commission Delegated Directive 2014/13/EU amends Annex IV to Directive 2011/65/EU regarding lead exemption in medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 18, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System. From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-06723. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 25, 2013 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of the State Food and Drug Administration Tianjin Center for Quality Supervision and Inspection of Medical Devices cardiac defibrillators and other medical equipment products and project testing qualifications notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2011-10313 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 22, 2011 Other (Public Domain) 0 reuses 0 favorites
Automated external defibrillators – safety updates From Health Products Regulatory Authority (HPRA) 🇮🇪 A document discussing safety updates related to Automated External Defibrillators (AEDs). Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
PMDA Medical Safety Information From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 Information for Medical Devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 10, 2024 Other (Public Domain) 0 reuses 0 favorites