The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The FDA granted Kimberly-Clark Health Care the first 510(k) clearance for a single-use pediatric face mask.
Designated as a Class II medical device, the colorful mask is used to protect the respiratory tracts of children ages five to 12 from various bacteria, viruses and pathogens. It’s intended for use in waiting rooms and hospitals, to protect already immuno-compromised children from further infection
FDA Clears New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System
PARK CITY, UTAH – September 13, 2011 – CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).
The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.
Medtronic Inc. (NYSE:MDT) won 510(k) clearance from the FDA for a pedicle screw designed to treat adolescent idiopathic scoliosis.
The Twin Cities medical device colossus said the FDA’s Center for Devices & Radiological Health gave the nod to its TSRH Spiral system pedicle screw. It’s the second Medtronic AIS treatment to land FDA clearance.
AIS is the most common pediatric spine condition, affecting nearly one million U.S. adolescents, according to the company.
CIRCA Scientific Announces That FDA Clears Its New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System
PARK CITY, Utah–(BUSINESS WIRE)–CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).
The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.
