SB Central Records

Posts Tagged ‘Manufacturer’

Originally conceived over twenty years ago, penile traction devices are designed to treat Peyronie’s disease, defined as an abnormal curvature of the penis. More recently this same medical technology has become increasingly popular as an alternative method to enlarge the penis. Traditionally, these types of extenders use spring tension to apply the traction force and use either a silicone band or strap to hold the penis in place. The method of fixation is often the main, sometimes only, diffe

Benlan Inc. is a medical device manufacturer specializing in disposable plastic products for the healthcare markets in Canada and the United States. The company operates a 100,000 square foot manufacturing facility in Oakville, Ontario where it manufactures molded and extruded medical components. Benlan is implementing ten new Plantnode units on multiple machines in their Oakville, Ontario facility. The company initially implemented Plantnode in April 2005 to assist them in gathering informa

A New Jersey-based company that makes tissue-based products used in open-heart surgeries is embroiled in a heated court battle and war of words with the Food and Drug Administration (FDA). This tension between Shelhigh and the FDA began April 17 when the federal regulatory agency pulled about 1 million parts at the company’s plant in New Jersey after a 10-week inspection of the facility in the fall of 2006. According to the civil complaint that the FDA filed in the U.S. District Court in