510(k) Latest News

Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory

Firm obtains FDA 510(k) clearances with assistance from Emergo Group

MediPurpose also announced that its expanding MediPlus(tm) advanced wound care product portfolio now includes Foam Ag, Comfort Foam Ag and Super Foam Ag dressings

An interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA.

This webinar will show how you can perform meaningful, results driven 510(k) / change analysis activities and reporting so as to satisfy FDA requirements.

An examination of publicly available FDA data by Emergo Group on 510(k) clearances over the last five years indicates that 80% of devices receive clearance within six months.

Manufacturer's line of products to treat snoring and sleep apnea cleared with assistance from Emergo Group.

AdvaMed affiliate, the State Medical Technology Alliance, appoints Heather Erickson, President of MedTech in upstate New York, and Joseph Panetta, President and CEO of BIOCOM in Southern California, as co-chairs.