Macromedics BV

Macromedics BV specializes in patient positioning devices primarily used in medical imaging. Their portfolio includes adjustable positioning boards like the FlexBoard™ and EagleBoard™, specialized breast supports such as the BreastBoard SXTM, vacuum cushions, foot supports, and lower extremity positioning systems (LEPS) to improve patient stability and comfort. They also offer modular DSPS-Prominent® baseplates and cradles, some designed for MRI compatibility, along with mask sets for head immobilization during procedures.

Macromedics BV is based in the United States. The company’s headquarters and operations are located within the country, aligning with its focus on manufacturing and distributing medical devices regulated by U.S. authorities.

Macromedics BV’s devices are listed in the FDA’s 510(k) registry. This registry includes Class II medical devices that have undergone the FDA’s 510(k) clearance process, demonstrating compliance with U.S. medical device regulations. The inclusion in this registry reflects the authorization status of individual devices rather than the company itself.

Macromedics BV’s devices fall under Class II classification according to U.S. medical device regulations. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. These devices must comply with the FDA’s 510(k) clearance process before being marketed.