All posts tagged Device Recall

Six Mistakes That Will Delay Your FDA 510k Submission

October 31, 2011 | No comments

In July 2011, the FDA conducted an analysis of its 510(k) data to determine the causes of increasing medical device …

Read more »

Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits

September 19, 2011 | No comments

The FDA is reporting a recall of custom dialysis trays/kits made by Lee Medical Int’l. These custom dialysis trays/kits contain …

Read more »

UPDATE on Life-Threatening Injuries Associated with the ShoulderFlex Massager

September 8, 2011 | No comments

The FDA released an update on its recall of the SHoulderFlex Massager. Current reports from the Consumer Product Safety Commission …

Read more »