Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask The Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
PR Newswire
Report Store
UsernamePublicRestriction
Tags:
Medical Device Regulation Compliance

FDA Warning Letters Released The Weeks Of April 8 And April 15

This article was originally published in The Gray Sheet

  • News

Executive Summary

FDA issues warning letters to device manufacturers in Canada, Italy, Japan and the U.S., including Baxter Healthcare Corp.

You may also be interested in...



NANS 2021: Nevro’s HF10 Spinal-Cord Stimulator Succeeds In Two Trials

SENZA PDN showed Nevro's HF10 spinal cord stimulation therapy provided sustained relief to patients with painful diabetic neuropathy. Results of a separate trial showed HF10 improved outcomes in patients with non-surgical refractory back pain.

Warning Letter Roundup & Recap – 19 January 2021

No device-related warning letters were released by the US FDA the week of 19 January.

Start-Up Spotlight: CorWave Takes Inspiration From Nature To Tackle Heart Failure

Following a €2.5m award from the European Commission’s EIC Accelerator Program, Paris based CorWave has become the first EU company to obtain EIC fund investment. The company is developing a new pulsatile LVAD.

Table

View full table

Topics

Tags:
Medical Device Regulation Compliance
UsernamePublicRestriction

Register

OM006665

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By