21 CFR Chapter I Subchapter H β Medical Devices β Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 days ago Other (Public Domain) 0 reuses 0 favorites
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
Medical Devices; Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access From Food and Drug Administration (FDA) πΊπΈ 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 andβ¦ 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
Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for industry and FDA staff on Investigational Device Exemptions (IDEs) for devices used in nocturnal home hemodialysis. 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for the submission of premarket notifications for hemodialysis blood tubing sets. 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Quality Assurance Guidelines for Hemodialysis Devices From Food and Drug Administration (FDA) πΊπΈ Guidance document providing quality assurance guidelines for hemodialysis devices. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on implanted blood access devices for hemodialysis. 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 February 9, 2019 Other (Public Domain) 0 reuses 0 favorites
Notice on the Implementation of YY0598-2006 "Concentrates for Hemodialysis and Related Treatments" Medical Device Industry Standard From National Medical Products Administration (NMPA) π¨π³ FGWJ-2006-10047 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 August 29, 2006 Other (Public Domain) 0 reuses 0 favorites
Notice on the release of 36 medical device industry standards including Hemodialysis, Hemodiafiltration and Hemofiltration Equipment From National Medical Products Administration (NMPA) π¨π³ FGWJ-2003-10115 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 June 20, 2003 Other (Public Domain) 0 reuses 0 favorites