21 CFR Chapter I Subchapter H – Medical Devices – Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 886 Ophthalmic 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 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
Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-26209. The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings… 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 30, 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
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-13954. The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD 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 June 30, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Mountable Electromechanical Surgical System for Transluminal Approaches From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-09749. The Food and Drug Administration (FDA, Agency, or we) is classifying the mountable electromechanical surgical system for transluminal approaches into class II (special controls). The special controls that apply to the device type are identified in this order and will be… 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
Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-08731. The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological use into class II (special controls). The special controls that apply to the device type are identified in this order and will be… 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, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-02357. The Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-27317. The Food and Drug Administration (FDA or we) is classifying the manual percutaneous surgical set assembled in the abdomen 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 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Information about BIA-ALCL for people with breast implants From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This advice has been written by the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) at the request of the Medicines and Healthcare products Regulatory Agency (MHRA – UK regulator). It is in the form of questions, asked of clinicians in consultation with their… 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 13, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26741. The Food and Drug Administration (FDA, Agency, or we) is classifying the negative pressure wound therapy device for reduction of wound complications 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 December 10, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25585. The Food and Drug Administration (FDA or we) is classifying the general laparoscopic power morcellation containment 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 November 23, 2021 Other (Public Domain) 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
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-22041. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I… 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 8, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry on the use of resorbable adhesion barrier devices in abdominal and/or pelvic surgery. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] From Food and Drug Administration (FDA) 🇺🇸 A guidance document outlining the checklist of information required for an Investigational Device Exemptions (IDE) application for refractive surgery lasers. 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
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document for the premarket notification of electrosurgical devices for general surgery, aimed at industry and FDA staff. 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 9, 2020 Other (Public Domain) 0 reuses 0 favorites
Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document for the premarket notification of bipolar electrosurgical vessel sealers for general surgery. 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
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-08260. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I (general… 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 24, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-06024. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety 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 April 1, 2019 Other (Public Domain) 0 reuses 0 favorites