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The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More
The agency has authority to exempt class II devices from requiring 510(k) submissions if it can determine that a 510(k) clearance is not necessary to assure their safety and effectiveness. Read More
CME America failed to include revisions made to its manufacturing operations in its device master record for the BodyGuard 323 Infusion Pump, according to a Form 483. Read More
The firm’s complaint procedure was found to be inadequate in that it lacked provisions for conducting a review of complaints to determine whether an MDR was required. Read More
An agency investigator found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated. Read More