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New York City startup Kinsa Health has won 510(k) clearance for its smartphone-connected thermometer for adults and children, the company announced Thursday. Read More
CME America failed to investigate the adequacy of its device labeling following three MedWatch reports on administration sets that related to the way a customer was using the device, according to a Form 483 issued to the Golden, Colo., devicemaker. Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More
At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
CAPA shortfalls identified during an FDA inspection in late August and September led to a recent Form 483 for Teleflex Medical. Among noted deviations, the company did not evaluate whether it should initiate a CAPA for distributed humidifier adaptor devices with seal defects. Read More
Lucero Medical, maker of the Enduramesh Corpectomy Spacer System, lacks design validation for the device, despite implantation of 89 of the vertebral body replacement systems by the time of an FDA inspection, according to a recent Form 483. Read More