21 CFR Chapter I Subchapter H – Medical Devices – Part 872 Dental Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 872 Dental 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 888 Orthopedic Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 888 Orthopedic 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
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry and FDA staff on premarket notification submissions for dental bone grafting material devices in animal studies. 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 March 28, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology 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 on June 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a draft guidance document for the premarket notification of orthopedic non-spinal bone plates, screws, and washers. 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 28, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 874 Ear, Nose, and Throat 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 on January 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Bone Indentation Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28601. The Food and Drug Administration (FDA, Agency, or we) is classifying the bone indentation 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 the codified language for the bone… 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 5, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-04154. The Food and Drug Administration (FDA, Agency, or we) is classifying the screw sleeve bone fixation 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 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 March 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on safety and performance criteria for orthopedic non-spinal metallic bone screws and washers. 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 December 10, 2020 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-17543. The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device… 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 August 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement From Food and Drug Administration (FDA) 🇺🇸 A guidance document for premarket testing of orthopedic implants with modified metallic surfaces apposing bone or bone cement. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on premarket notification submissions for bone anchors. 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-23412. The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing 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 language… 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 26, 2018 Other (Public Domain) 0 reuses 0 favorites
Notice of the General Office of the Food and Drug Administration on the Definition of Classification of 127 Products including Multi-functional Ultrasonic Bone Knife From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2015-10265 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 July 20, 2015 Other (Public Domain) 0 reuses 0 favorites
Notice of Clarification of Management Categories for Bone Cement Cannula Components and Vertebral Body Expansion (Forming) Devices From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10121 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 6, 2010 Other (Public Domain) 0 reuses 0 favorites
On the release and implementation of YY 0017-2008 "bone joint implant metal bone plate" and other 64 medical device industry standards notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2008-10186 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 October 17, 2008 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers From Food and Drug Administration (FDA) 🇺🇸 Document number E8-16354. The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies… 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 17, 2008 Other (Public Domain) 0 reuses 0 favorites