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
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-19736. The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive open loop fluid therapy recommender into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified… 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 2 weeks ago Other (Public Domain) 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) 🇺🇸 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 type… 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) 🇺🇸 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 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 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28168. The Food and Drug Administration (FDA, Agency, or we) is classifying the extracorporeal system for carbon dioxide removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified… 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 29, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28173. The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of… 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 28, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28131. The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive hemodynamic indicator with decision point into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… 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 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-12364. The Food and Drug Administration (FDA or we) is classifying the intravascular bleed monitor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intravascular… 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 8, 2022 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) 🇺🇸 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 the… 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
Medical Devices; Cardiovascular Devices; Classification of the Reverse Central Venous Recanalization System From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-09745. The Food and Drug Administration (FDA, Agency, or we) is classifying the reverse central venous recanalization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified… 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 May 6, 2022 Other (Public Domain) 0 reuses 0 favorites
Presentation: Medical device regulatory lifecycle and clinical evidence requirements From Therapeutic Goods Administration (TGA) 🇦🇺 TGA presentation slides from Queensland Cardiovascular Research Network Webinar (25 June 2021). 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 April 20, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-03496. The Food and Drug Administration (FDA or we) is classifying the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into class II (special controls). The special controls that apply to the device type are identified in this order and… 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 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-03096. The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for… 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 14, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Photoplethysmograph Analysis Software for Over-the-Counter Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-02358. The Food and Drug Administration (FDA, Agency, or we) is classifying the photoplethysmograph analysis software for over-the- counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of… 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-00827. The Food and Drug Administration (FDA, Agency, or we) is classifying the electrocardiograph software for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… 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 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on cardiovascular intravascular filter 510(k) submissions. 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 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-01638. The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and… 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 30, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-15901. The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the… 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 July 28, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-15786. The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for… 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 July 27, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-25002. The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's… 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 17, 2016 Other (Public Domain) 0 reuses 0 favorites