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The dual-use device provides low-dose, high quality images with premium flat detector technology, eliminating the need for several frames to produce a useable image for diagnosis. Read More
In the trial, the company will explore the bone graft’s use as it compares to autografts in transforaminal lumbar interbody fusion procedures meant for treating degenerative disk disease. Read More
The investigator observed that the firm’s device master record for fixation screws did not define certain specifications, including packaging, labeling, acceptance criteria and quality assurance. Read More
The FDA was not impressed with Korean devicemaker Dexcowin’s responses to a Form 483 it received following an August 2017 inspection of its facility in Seoul. The agency received two responses from the manufacturer of portable dental X-rays, but then issued a 13-item warning letter. Read More
FDA investigators uncovered numerous quality system deficiencies during a December 2017 inspection of Laser Dental Innovations’ San Jose, California plant. Read More
Revisions to the country’s Therapeutic Products Act and Human Research Act will be followed by a complete overhaul of its Medical Devices Ordinance and a new ordinance for in vitro diagnostics. Read More
The agency received nearly 12,000 adverse event reports relating to Essure last year, the majority of which were submitted in the last quarter of the year. Read More