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R&D Engineering, a maker of kidney transport trays, received an FDA warning letter for failing to secure identification labels on devices, among other quality issues. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
Ventlab received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, industry experts say. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
IBSA Farmaceutici did not open a corrective action, as required, for a trend in adverse events involving pain and/or swelling in the knee following injection of Sinovial or other sodium hyaluronate devices, according to a Form 483. Read More
Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues. Read More