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Browsing: Clearance
Boston Micro Fabrication (BMF), a leader in advanced manufacturing solutions for ultra-high precision applications, announced that it has received 510(k) clearance from the US Food and…
Sofwave Medical Receives 510(k) Marketing Clearance for Pure Impact™ Strength and Body Muscle Unit Using PlyoPulse™ EMS Technology
SofWave Medical, Ltd.Pure Impact™ with PlyoPulse™ Technology is a direct add-on Body module to Sofwave’s existing FDA-cleared medical aesthetic device platformPlyoPulse™ technology is an EMS (Electrical…
Stay up to date with all that is happening in the wonderful world of AM through our LinkedIn community. The Food and Drug Administration (FDA) has…
Sofwave Medical Receives FDA Clearance for SUPERB™ Technology to Improve Appearance of Upper Arm Skin Laxity
SofWave Medical, Ltd.The FDA clearance is supported by extremely compelling clinical study results showing that 93% of treated subjects were “improved” or “much improved” in appearance…
Align Technology Receives US FDA 510(k) Clearance for Invisalign® Palatal Expander System to Address Skeletal and Dental Expansion in Growing Patients, Including Adolescent Patients Who Represent the Majority of Orthodontic Initiations Worldwide
Invisalign® Palatal Expanders offer doctors a removable, safe and clinically effective alternative to traditional palatal expanders.Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with…
3D systems (NYSE:DDD) announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for NextDent Base that is, material intended for the manufacture of…
Andrew Technologies Receives FDA 510(k) Clearance for Commercial Version of HydraSolve™ Lipoplasty System
IRVINE, CA., December 17, 2012 /PRNewswire/ — Andrew Technologies, LLC has received FDA 510 (k) clearance for the commercially manufactured version of the HydraSolve™ Lipoplasty System,…