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Displaying items by tag: FDA
The Food and Drug Administration granted 14 spine device-related clearances in April, according to an FDA report.
The Food and Drug Administration granted 33 orthopedic- and spine-related device clearances in April.
The Food and Drug Administration granted 17 spine-related medical device clearances in March.
Biotechnology company Arteriocyte has received approval from the Food and Drug Administration to initiate a Phase I clinical trial with its Magellan MAR01 technology for treating compartment syndrome in extremity trauma patients.
The Food and Drug Administration granted 38 orthopedic- and spine-related medical device clearances in March.
The Food and Drug Administration has issued Lucero Medical a letter of warning related to its spinal fusion device Enduramesh.
The Food and Drug Administration will hold a two-day expert review on metal-on-metal hip replacements that may result in new standards for the device, according to a New York Times report.
Two Murrieta, Calif.-based medical device companies have received warnings from the Food and Drug Administration for a lack of quality control over the manufacturing or assembling process.
The Food and Drug Administration published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during the pre-market review.
Ascendx Spine announced it received FDA 510(k) clearance for its Acu-Cut Vertebral Augmentation System for treating vertebral compression fractures.
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