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Custom Ultrasonics is a medical device company that specializes in the development and manufacturing of automated endoscope reprocessors (AERs). The company's primary product line, the System 83 Plus series, is designed to provide high-level disinfection and cleaning for flexible endoscopes used in various medical procedures. Headquartered in Ivyland, Pennsylvania, the firm focuses on infection prevention solutions for healthcare facilities, particularly in gastroenterology and pulmonary medicine. Custom Ultrasonics has a complex regulatory history, having operated under a long-term FDA consent decree and facing significant recall orders in the mid-2010s. Today, it continues to provide equipment, accessories, and maintenance services to the endoscopy market.
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