Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
Cook Medical has received the 510(k) approval from the US Food and Drug Administration (FDA) for its Evolution Biliary Controlled-Release Uncovered Stent. Adding to the Cook's line of Evolution controlled-release stents for the ...
Tags: Cook Medical, Biliary Stent
Blue Belt, next generation surgical orthopedic instruments developer, has received 510(k) approval from the US Food and Drug Administration (FDA) to market its Stride Unicondylar Knee implant system. With the clearance, the Stride implant ...
Tags: Blue Belt, FDA Approval
DiFusion Technologies has received the US Food and Drug Administration's (FDA) approval for its Vestakeep Peek-based Xiphos ALIF (polyetheretherketone) spinal implant for use in Interbody Fusion (IBF) devices. Evonik's Vestakeep Peek is ...
The US-based CAS Medical Systems (CASMED) has received the US Food and Drug Administration (FDA) 510(k) approval for its next-generation Fore-Sight Elite Absolute Tissue Oximeter. The Fore-Sight ELITE Oximeter, which is capable of ...
Tags: Casmed, Absolute Tissue Oximeter
The US Food and Drug Administration (FDA) has granted 510(k) approval to CryoLife's new Hemodialysis Reliable Outflow (HeRO) device. The device, which the company claims, is the only subcutaneous AV access solution that maintains ...
Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The ...
Tags: Quidel, Life Technologies, FDA Approval
The US Food and Drug Administration (FDA) has granted 510(k) approval to Vital Images' CT transcatheter aortic valve replacement (TAVR) planning application. TAVR procedures, in general, use endovascular techniques to replace faulty ...
US-based Modern Plastics has announced that a spinal implant device using Evonik's VESTAKEEP PEEK (polyetheretherketone) has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The implant device, which exhibits ...
Tags: Modern Plastics, Evonik, VESTAKEEP PEEK, FDA
The US Food and Drug Administration (FDA) has granted 510(k) approval to Zoll Medical's fully automatic version of ZOLL AED Plus. Using the company's proprietary feedback technology, Real CPR Help, the new fully automatic device provides ...
Tags: FDA, ZOLL AED Plus, Medical
The US Food and Drug Administration (FDA) has granted 510(k) approval to Ethicon Endo-Surgery's ENSEAL G2 Articulating Tissue Sealer, designed to allow surgeons to take a perpendicular approach to seal vessels up to 7mm in diameter and ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Varian Medical Systems' Vitesse brachytherapy treatment planning solution. The CE-marked solution enables clinicians to plan and perform high-dose-rate (HDR) ...
Tags: FDA, Varian Medical Systems
The US Food and Drug Administration (FDA) has granted 510(k) approval to Teleflex's ARROW UltraQuik peripheral nerve block (PNB) needles. UltraQuik PNB needles help clinicians to increase overall block success, while using ...
Tags: FDA, Teleflex, UltraQuik PNB needles
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Insulet has gained the US Food and Drug Administration's (FDA) 510(k) approval for its new version of tubeless insulin pump. The new easy-to-use OmniPod insulin management system features the same 200-unit insulin reservoir capacity, ...
Tags: FDA, Insulet, tubeless insulin pump, clinical technology