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Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More
Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain. Read More
The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Teva’s iontophoretic transdermal patch Zecuity to treat acute migraine headaches. Read More