21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological 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 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice on Medical Devices From National Organization for Medicines (EOF) 🇬🇷 Notice concerning products applied to the skin with health claims (muscle pain, joint pain, etc.), containing camphor and/or ... 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 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery 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 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin From Therapeutic Goods Administration (TGA) 🇦🇺 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; General and Plastic Surgery Devices; Reclassification of Blood Lancets From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25376. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class… 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 November 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA reviewers/staff on premarket notification submissions for testing skin sensitization to chemicals in natural rubber products. 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; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00295. The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels… 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 14, 2020 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices; Reclassification of Blood Lancets From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-04578. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into… 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 3, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Limited Output Transcutaneous Piezoelectric Stimulator for Skin Reactions Associated With Insect Bites From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-06499. The Food and Drug Administration (FDA) is classifying the limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites into class II (special controls). The special controls that will apply to the device are identified in this… 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 23, 2015 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-12546. The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming… 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 2, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-08940. The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid… 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 April 21, 2014 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-10982. The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them… 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 9, 2013 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-02862. The Food and Drug Administration (FDA) is proposing to classify the eyelid weight into class II (special controls). The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid… 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 8, 2013 Other (Public Domain) 0 reuses 0 favorites
ARGB Appendix 8 - Guidance on TGO 86 From Therapeutic Goods Administration (TGA) 🇦🇺 Standards for human skin. This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements. 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 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-9899. The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than… 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 April 25, 2011 Other (Public Domain) 0 reuses 0 favorites
Skin glue DERMABOND From National Organization for Medicines (EOF) 🇬🇷 The EOF informs you that Johnson & Johnson's Ethicon has issued an emergency voluntary recall of multiple lots of its skin adhesive ... 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 4, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct Wound Closure Device Intended for Topical Approximation of Skin From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-28356. The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance… 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 November 10, 2010 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices: Proposed Classification for the Tissue Expander From Food and Drug Administration (FDA) 🇺🇸 Document number E8-30439. The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop… 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 22, 2008 Other (Public Domain) 0 reuses 0 favorites