FDA warns Surgisil for unapproved facial implant marketing

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– The FDA has issued a warning letter to Signal Medical Corp. for selling a hip implant with "major changes" that were never approved.. During inspections in July and August 2014, the FDA found that Signal was selling the MicroSeal hip replacement with design modifications that had never been evaluated for safety or effectiveness.

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Surgisil Warned for Unapproved Marketing of Facial Implant. Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks.. The FDA issued a.

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FDA issued a Warning Letter to a medical device company that manufactures a facial implant device due to a number of deficiencies found during a 2018 inspection. Based on the inspection, FDA found that the company’s marketing materials for the device, including instructional videos and.

The SurgiSilTM Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSilTM Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm.

FDA warns against unapproved concussion. “The FDA has identified several manufacturers that were marketing medical devices for. textured breast implant.