Diality wins FDA clearance for hemodialysis system
August 6, 2024
Diality announced today that it received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system.
Diality announced today that it received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system.
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer.
Inspire Medical Systems (NYSE: INSP)+ announced today that it received FDA approval for its Inspire V therapy system.
MiRus announced that it received FDA breakthrough device designation for its Europa posterior cervical system for the spine.
Stryker (NYSE: SYK)+
announced today that it received FDA 510(k) clearance for its Q Guidance System with Spine Guidance 5 software featuring Copilot.
Siemens Healthineers‘ Varian announced that it received FDA 510(k) clearance for its IntelliBlate microwave ablation system.
Extension to Indications for Use follows submission of results from a human factors study evaluating the safe and effective use of the device in the home care setting.
CorVascular announced today that the FDA granted clearance for its VasoGuard V-Series portfolio of devices.
Asensus Surgical (NYSE:ASXC) announced today that it received FDA 510(k) clearance for an expanded surgical robot indication.
FREMONT, Calif., July 23, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System (TMINI 1.1) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).