Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler […]
510(k)
FDA releases September 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2016 TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 7 DEVICE: BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. 510(k) NO: K142846(Traditional) ATTN: EBLESS V BAEZ ALERS PHONE NO : 787 8440345 SAN ANTONIO DRAMA ST. 2067 SE DECISION MADE: […]
FDA releases August 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2016 TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 17 DEVICE: CompleClear Plastic Orthodontic Bracket and Wire Appliance ORACREW 510(k) NO: K150830(Traditional) ATTN: PAWAN GAUTAM PHONE NO : 1 760 2370163 210 E Flamingo Rd. #217 SE DECISION […]
Spineology wins FDA 510(k) for Rampart Duo interbody fusion device
Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease. The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device […]
FDA clears pediatric spine implants from Medicrea
Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients. The New York City and Lyon, France-based company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed […]
Philips wins FDA nod for Lumify S4-1 transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device. The newly cleared S4-1 transducer is pocket-sized and lightweight, Philips touted, designed to improve sensitivity and provide high-resolution 2D images. “Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands […]
Fresenius Kabi wins FDA nod for Aurora Xi plasmapheresis system
Fresenius Kabi (NYSE:FMS) said today that it won FDA 510(k) clearance for its Aurora Xi plasmapheresis system. Plasma, a component of blood that contains proteins, is used in therapies to treat burn victims, bleeding disorders, and other chronic and genetic problems. Patients who require plasma infusions or injections have to get them regularly and often […]
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Becton Dickinson wins 510(k) for Vacutainer Barricor tubes
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube. The Franklin Lakes, N.J.-based company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency. “As we launch […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]