List Of Approved Medical Devices

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2020 Device Approvals FDA

(3 days ago) 61 rows · Medical Devices Cleared or Approved by FDA in 2020. Device Name. Category. Date. Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) System - P150031/S028. Implantable Pulse Generator

https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals

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List of Medical Devices, by Product Code, that FDA

(Just Now) List of Medical Devices, by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA

https://www.fda.gov/media/85192/download

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Medical Device Databases FDA

(Just Now) 26 rows · An approved Premarket Approval Application (PMA) is, in effect, a private license granted to …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

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3.6 Medical devices: National lists

(7 days ago) List of approved medical devices for procurement or reimbursement: The survey revealed that 98 countries do not have any national list of approved medical devices for procurement or reimbursement in the country (57% of 173 respondent countries). In addition, looking at the 75 countries that have a

https://www.who.int/medical_devices/priority/3_6.pdf?ua=1

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Device Approvals, Denials and Clearances FDA

(7 days ago) Recently Approved Devices that include some of the newest medical technology available. Monthly listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisions Information on

https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances

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List of Approved Medical Devices

(4 days ago) list of approved medical device for 2008 As of November 6, 2009 B. Braun Medical Supplies, Inc. Certofix Trio Paed Central Venous Catheter Set, S520 BHDT-R-2008-098 7510 9-8-09

https://www.who.int/medical_devices/survey_resources/medical_devices_for_procurement_reimbursement_philippines.pdf

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List of Approved Products Pharmaceuticals and Medical

(3 days ago) JCN 3010005007409. Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0001.html

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Compliant Devices List

(Just Now) Ohio Medical Marijuana Control Program Compliant Devices List UPDATED 7/8/2021 . Compliant Device List Page 1 of 6. This document identifies devices that have been submitted to the MMCP for review and—based on representations made at the time of submission—were determined to be compliant with Program rules. Devices were determined to

https://medicalmarijuana.ohio.gov/Documents/LicenseeResources/Dispensary%20Licensee%20Resources/DISPENSARY%20GENERAL%20OPERATIONS/Compliant%20Devices%20List.pdf

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IS there any database for list of CE marked Medical

(7 days ago) Re: IS there any database for list of CE marked Medical devices and there current sta. Such a database does not exist. But it will be introduced by the incoming Medical Device Regulations. But this database (EUDAMED) will not be publicly accessible. Instead, …

https://elsmar.com/elsmarqualityforum/threads/is-there-any-database-for-list-of-ce-marked-medical-devices-and-there-current-status.72115/

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List of approved wearable medical devices

(4 days ago) evaluated and approved by a regulatory agency. The approval means that both patients and clinicians can make treatment decisions based on data reported by the device. Some of the well-known medical device agencies are Therapeutic Goods Administration (TGA) in Australia,

https://www.hisa.org.au/wp-content/uploads/2018/03/List-of-approved-wearable-medical-devices_Robab-Abdolkhani-.pdf

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Medical Devices Active Licence Listing (MDALL)

(8 days ago) The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate (Compliance and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

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Updated list of medical devices required to be registered

(2 days ago) the full regulation of all medical devices. The list is based on the BFAD Memorandum No. 7 s. 1992 that identifies the list of registrable medical devices and from the consolidated database of registered medical devices. The following is the initial list of medical devices and in-vitro diagnostic medical devices that are required for mandatory

https://www.asiaactual.com/wp-content/uploads/2017/12/FMC2014-005-Updated-List-of-Medical-Devices-required-to-be-Registered-Prior-to-Sale-Distribution-and-Use.pdf

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BP monitoring you can count on—list of validated devices

(Just Now) With the expansion, the VDL now features five manufacturers, A&D Medical, Hillrom-Welch Allyn, Microlife, Omron and PharmaSmart. These additional BP measurement devices have been approved for listing on the VDL, and can be viewed at ValidateBP.org. Additional manufacturer submissions will be reviewed by the IRC on an ongoing basis.

https://www.ama-assn.org/delivering-care/hypertension/bp-monitoring-you-can-count-list-validated-devices-grows

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Reprocess Approved Single-Use Devices

(4 days ago) Description. Single-use medical device (SUD) reprocessing and remanufacturing can be the cornerstone of your environmental initiative by saving costs and reducing waste. FDA-approved third-party manufacturers can provide advanced services that more responsibly use resources, deliver supply-cost savings, and lessen the impact on the environment.

http://www.sustainabilityroadmap.org/pims/27

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Complete list of eligible HSA expenses for 2021

(4 days ago) Complete list of eligible HSA expenses for 2021. This is the internet's first and only complete list of both HSA-eligible and ineligible expenses. Bookmark this page so you can always spend your HSA funds in the smartest way possible. Please note that this site is an educational reference only—not all health savings accounts are the same, and

https://www.hsalist.org/

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10 FDA Cleared or Approved Wearable Devices that Redefined

(6 days ago) And the companies that have developed these wearable medical devices are diverse too. Big tech giants and small startups all have a seat at the wearable medical device market’s table. MD+DI has compiled a list of 10 cleared or approved wearable medical devices by FDA that have redefined healthcare.

https://www.mddionline.com/digital-health/10-fda-cleared-or-approved-wearable-devices-redefined-healthcare

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Approved Evidential Breath Measurement Devices US

(3 days ago) Overview Evidential Breath Testing (EBT) devices on this page are the only devices you may use to conduct alcohol confirmation tests under 49 CFR Part 40. These EBTs may also be used to conduct alcohol screening tests under Part 40. To conduct a confirmation test, you must use an EBT that has the following capabilities:

https://www.transportation.gov/odapc/Approved-Evidential-Breath-Measurement-Devices

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Durable Medical Equipment Coverage

(2 days ago) Durable medical equipment (DME) coverage. Medicare Part B (Medical Insurance) covers Medically necessary DME if your doctor prescribes it for use in your home. DME that Medicare covers includes, but isn't limited to: Blood sugar meters. Blood sugar test strips. Canes.

https://www.medicare.gov/coverage/durable-medical-equipment-dme-coverage

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US FDA Approved Materials (which can be used for Medical

(1 days ago) There is no such US FDA definition. Any material can be used in a medical device if it's safe and effective in the application. Probably what the vendor means is either that the material conforms to a Standard that is Recognized by US FDA, or that the material has been subjected to an appropriate series of ISO 10993 biocompatibility tests by somebody--its maker, the vendor, or someone else

https://elsmar.com/elsmarqualityforum/threads/us-fda-approved-materials-which-can-be-used-for-medical-devices-list.50726/

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List of medical devices given exceptional use

(5 days ago) Device/model name: Rapid COVID-19 (Antigen) Self-test to detect positive cases amongst asymptomatic people, one-off testing prior to an activity to reduce risks, …

https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations

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Medical Equipment List Saudi Food and Drug Authority

(5 days ago) All The Authority Food Drugs Medical Devices fodder Pesticides Laboratories Cosmetics Tobacco Halal. Areas . All The Authority Food Drugs Medical Devices fodder Pesticides Laboratories Cosmetics Tobacco Halal . Regulations forms Circulars FAQ. Regulations forms Circulars FAQ.

https://sfda.gov.sa/en/medical-equipment-list

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FDA Approved Class II Medical Device

(9 days ago) US FDA Approved Materials (which can be used for Medical Devices) List? Other US Medical Device Regulations: 3: Oct 9, 2011: V: Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site: ISO 13485:2016 - Medical Device

https://elsmar.com/elsmarqualityforum/threads/fda-approved-class-ii-medical-device.77870/

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Medical devices for expanded COVID-19 use: Authorized

(1 days ago) Medical devices on this list have an expanded indication for use or intended use related to COVID-19. Diagnostic, treatment, mitigation or prevention claims are based on known evidence as outlined in section 13 of Interim Order No. 1 for importing and selling medical devices (March 18, 2021, to March 1, 2021) or section 14 of Interim Order No. 2 for importing and selling medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/expanded-use.html

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Medical devices & IVDs Therapeutic Goods Administration

(3 days ago) Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves. Face masks and COVID-19. Compilation of resources related to face masks and

https://www.tga.gov.au/medical-devices-ivds

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Medical device & diagnostics

(4 days ago) 6.Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient- Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment

https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/

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Approved bodies for medical devices

(4 days ago) An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices

https://www.gov.uk/government/publications/approved-bodies-for-medical-devices/approved-bodies-for-medical-devices

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Durable Medical Equipment Reference List (NCD 280.1)

(8 days ago) Durable Medical Equipment Reference List (NCD 280.1) Page 1 of 21 UnitedHealthcare Medicare Advantage Policy Guideline Approved 08/12/2020 Proprietary Information of UnitedHealthcare.

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/d/durable-medical-equipment-dme-reference-list.pdf

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HSA Medical devices

(8 days ago) Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to: Diagnose, alleviate or treat a medical condition, e.g. X-ray machines, contact lenses, prosthetic knee implants. Measure or monitor functions of the body, e.g. blood pressure or blood sugar monitoring machines.

https://www.hsa.gov.sg/medical-devices

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Publication 502 (2020), Medical and Dental Expenses

(7 days ago) Medical expenses include dental expenses, and in this publication the term "medical expenses" is often used to refer to medical and dental expenses. You can deduct on Schedule A (Form 1040) only the part of your medical and dental expenses that is …

https://www.irs.gov/publications/p502

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COVID-19 testing devices: Authorized medical devices

(3 days ago) For other types of COVID-19 devices, see the list of authorized medical devices other than testing devices. Point-of-care testing devices are used by an approved operator (often a health care professional) in a near-patient environment like a medical office or at …

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/list.html

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Medical devices European Medicines Agency

(Just Now) A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be CE marked. Examples of medical devices with an ancillary medicinal substance include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent and condoms coated

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

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Medicines/Finished Pharmaceutical Products WHO

(2 days ago) EMA Art. 58 - approved by EMA according to Article 58 Note: For information about the listing of prequalified products and the alternative approval procedure, please see: General Information

https://extranet.who.int/pqweb/medicines/prequalified-lists/finished-pharmaceutical-products

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Treasury Expands List of Basic Medical Supplies Authorized

(Just Now) In today’s action, OFAC expanded the list of basic medical supplies authorized for export or reexport under an existing general license, originally issued in October 2012, to encompass a broad range of medical supplies and devices, including electrocardiography machines (EKGs), electroencephalography machines (EEGs), and dialysis machines

https://www.treasury.gov/press-center/press-releases/Pages/jl2123.aspx

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Medical Device Regulations in Russia and Eurasian Union

(5 days ago) Changes in Tax Regulations for Certain Groups of Medical Devices in Russia. On 1 June 2021, the Russian government published Resolution 851 ( link in Russian) and updated the list of medical devices taxed at a decreased rate of 10%, approved by Decree of the Government of the Russian Federation N 688.

https://medicaldevicesinrussia.com/

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WHO Priority medical devices for COVID prevention

(7 days ago) The list of priority medical devices in the context of COVID-19 provides descriptions for the management of patients with severe acute respiratory infection (SARI) when a COVID-19 virus infection is suspected at different levels of health care provision.

https://www.who.int/medical_devices/priority/COVID-19/en/

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Recognized Consensus Standards

(4 days ago) 60601-1-12 Edition 1.0 2014-06. Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm

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CHINA CHAMBER OF COMMERCEFOR IMPORT&EXPORT OF …

(6 days ago) Name List of Medical Devices and Supplies Companies with Certific… Updated: Jnly 15, 2021. Global Health Industry Cooperation Conference & Conference on Chi… China-CEEC Cooperation for Public Health Industry Officially Launched. Name List of Non-Medical Use Face Masks Companies with Certificat… Updated: June 29, 2021

http://en.cccmhpie.org.cn/

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The 17 most innovative medical devices of 2019 Medical

(4 days ago) The 17 most innovative medical devices of 2019. The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition.

https://www.medicaldesignandoutsourcing.com/17-most-innovative-medical-devices-2019/

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Notified Medical Devices in India

(Just Now) Notified Medical Devices: Medical Device Registration Process in India Background. The recent political changes resulting in a pro-business environment has made manufacturers from the Healthcare industry stand up and take notice of India. The Industry is expected to grow at a high CAGR of 15 percent for the next five years and is predicted to become a US $155 billion market by 2017.

https://morulaa.com/indian-medical-device-market/notified-medical-devices-india/

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