21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) πΊπΈ A regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β 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
Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems From Therapeutic Goods Administration (TGA) π¦πΊ Publication of submissions to the public consultation paper Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems From Therapeutic Goods Administration (TGA) π¦πΊ Updated guidance to reflect new amendments made to the regulations. 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 January 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate From Food and Drug Administration (FDA) πΊπΈ Document number 2023-01967. The Food and Drug Administration (FDA, Agency, or we) is classifying the software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device typeβ¦ 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 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate From Food and Drug Administration (FDA) πΊπΈ Document number 2023-00010. The Food and Drug Administration (FDA, Agency, or we) is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply toβ¦ 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 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals From Food and Drug Administration (FDA) πΊπΈ Document number 2022-11699. The Food and Drug Administration (FDA or we) is classifying the coronary artery disease risk indicator using acoustic heart signals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of theβ¦ 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 June 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Reporting adverse incidents: biological and mechanical surgical heart valves From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ For manufacturers reporting adverse incidents with biological/mechanical surgical heart valves under the vigilance system. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on December 30, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 271 of 14/03/2019 From Brazilian Health Regulatory Agency (Anvisa) π§π· Provisionally regulates the reprocessing of perfusion cannulas for heart surgery and catheters used in electrophysiological procedures. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2019 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation From Food and Drug Administration (FDA) πΊπΈ Document number 2013-31218. The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non- cardiac surgery, or complications of heart failure, a preamendments classβ¦ 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 December 30, 2013 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses From Food and Drug Administration (FDA) πΊπΈ Document number 2013-14553. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify intra-aortic balloon and control system devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, aβ¦ 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 June 19, 2013 Other (Public Domain) 0 reuses 0 favorites
Notice on the Accreditation of China National Institute for Testing of Pharmaceutical and Biological Products for Testing of Products and Items of Medical Devices such as Prosthetic Heart Valves and Other Medical Devices From National Medical Products Administration (NMPA) π¨π³ FGWJ-2010-10163 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice on the Results of Product Quality Supervision and Testing of Ultrasound Doppler Fetal Heart Rate Monitor and Other Products From National Medical Products Administration (NMPA) π¨π³ FGWJ-2006-10200 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 23, 2006 Other (Public Domain) 0 reuses 0 favorites
Notice on the Accreditation of China National Institute for the Control of Pharmaceutical and Biological Products for Testing of Prosthetic Heart Valves and Other Products and Items From National Medical Products Administration (NMPA) π¨π³ FGWJ-2005-10086 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 January 18, 2005 Other (Public Domain) 0 reuses 0 favorites
Notice on the Publication of 5 Medical Device Industry Standards, including Ultrasound Doppler Fetal Heart Rate Monitor From National Medical Products Administration (NMPA) π¨π³ FGWJ-2003-10191 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 February 9, 2003 Other (Public Domain) 0 reuses 0 favorites