What are the considerations for ensuring equitable access to medical devices cleared through 510(k)?

In Stock

Size Guide

$34.99 $29.99

Shipping and Returns Policy

Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... Apr 19, 2023 ... At this time, the FDA does NOT approve hearing aids, and no one can claim that a hearing aid is FDA-approved. What is 510(k) FDA approval? Mar 9, 2022 ... Information that supported 510(k) cleared assays is publicly available! ... What does this mean? • Intended only for Employment and ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... FDA 510(k) Medical Device Clearance. The 510(k) pathway is based on ... A claim of substantial equivalence does not mean the device(s) must be identical. Mar 14, 2024 ... The US Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company's next-generation multiport robotic system. Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. Feb 4, 2025 ... FDA clearance through the 510(k) process means the agency agrees ... What does it mean to be 510(k) exempt? Some medical devices are ...
  • Next Day Delivery by USPS Find out more

    Order by 9pm (excludes Public holidays)

    $11.99

  • Express Delivery - 48 Hours Find out more

    Order by 9pm (excludes Public holidays)

    $9.99

  • Standard Delivery $6.99 Find out more

    Delivered within 3 - 7 days (excludes Public holidays).

  • Store Delivery $6.99 Find out more

    Delivered to your chosen store within 3-7 days

    Spend over $400 (excluding delivery charge) to get a $20 voucher to spend in-store
  • International Delivery Find out more

    International Delivery is available for this product. The cost and delivery time depend on the country.

You can now return your online order in a few easy steps. Select your preferred tracked returns service. We have print at home, paperless and collection options available.

You have 28 days to return your order from the date it’s delivered. Exclusions apply.

View our full Returns and Exchanges information.

Our extended Christmas returns policy runs from 28th October until 5th January 2025, all items purchased online during this time can be returned for a full refund.

No reviews yet. Only logged in customers who have purchased this product may leave a review.