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The FDA hit Smith & Nephew with a warning letter for quality, CAPA and procedural issues related to its Truclear Ultra Reciprocating Morcellators 4.0. Read More
LuSys Laboratories is recalling all lots of its Ebola Virus One-Step test kits because the kits haven’t been shown to be accurate for the disease. Read More
The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Devicemakers should submit new electronic Medical Device Reports several days before the deadline or risk being considered late under U.S. FDA requirements that take effect Aug. 14. Read More