The US Food and Drug Administration (FDA) has granted 510(k) approval to Cardiosolutions' Dexterity Steerable Introducer. The Dexterity Steerable Introducer is designed to simplify the cardiac trans-septal procedure and facilitates ...
Spacelabs Healthcare, a division of OSI Systems, has received the US Food and Drug Administration's 510(k) approval for its Blease900 ventilator. The Blease900 ventilator, which is an integral component of its BleaseFocus anesthesia ...
Tags: FDA, OSI Systems, Blease900 ventilator
Spacelabs Healthcare, a subsidiary of OSI Systems, has obtained 510(k) approval for its new compact, sidestream gas analyzer, Capnography Pod, from the US Food and Drug Administration (FDA). Capnography Pod, which is compatible with the ...
Tags: Spacelabs, OSI Systems, approval, FDA
Spacelabs Healthcare, a division of OSI Systems, has received 510(k) approval from the US Food and Drug Administration (FDA) for its AriaTele telemetry transmitter. AriaTele transmitter features an onboard display screen that presents ...
Tags: Spacelabs Healthcare, OSI Systems, AriaTele telemetry transmitter
The US Food and Drug Administration (FDA) has granted 510(k) approval to Reflectance Medical's CareGuide Oximeter. CareGuide Oximeter monitors hemoglobin oxygen saturation of microvascular blood in skeletal muscle tissue (muscle ...
Tags: FDA, CareGuide Oximeter, clinical technology
The US Food and Drug Administration (FDA) has granted 510(K) approval to Cytomedix to use its Angel Concentrated Platelet Rich Plasma (cPRP) system to process a small sample of blood or a mixture of blood and bone marrow aspirate. ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Kinetic Concepts for new indication use of vacuum assisted closure (VAC) therapy system. The new indication for VAC therapy for closed incision management will ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections. ...
Tags: FDA, wound film dressing, clinical product, clinical application
The US Food and Drug Administration (FDA) has granted 510(k) approval to Surefire Medical's High-Flow Microcatheter. The Surefire Microcatheter, comprising of expandable tip, is designed to deliver therapy with higher infusion ...
Nanosphere has obtained the US Food and Drug Administration's (FDA) 510(k) approval for its infectious C difficile test, designed for use on the sample-to-result Verigene system. By automating the steps of bacterial DNA extraction, ...
Tags: Nanosphere, difficile test, verigene system, health
The US Food and Drug Administration(FDA)has granted 510(k)approval to Blue Belt Technologies'orthopedic surgical system for use in Unicondylar Knee Replacement(UKR)procedures. Using the company's patented technology,the CE-marked NavioPFS ...
Tags: Blue Belt Technologies'orthopedic surgical system, UKR, NavioPFS system
IRIDEX has obtained FDA's 510(k) approval and CE mark for its non-invasive laser delivery system, designed for treating serious retinal diseases. Using MicroPulse technology, the new TxCell Scanning laser delivery system saves time in a ...
Tags: IRIDEX, non-invasive, laser delivery system, CE mark approvals
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medtronic's Aquamantys3 BSC 9.1S bipolar sealer with cutting, designed for use in orthopaedic surgery. By utilizing Transcollation technology, the BSC 9.1S Bipolar ...
Tags: FDA, 510(k)approval, orthopaedic surgery, transcollation technology
The US Food and Drug Administration (FDA) has granted 510(K) approval to KFx Medical's AppianFx Tissue Fixation Anchor. The 5mm AppianFx Tissue Fixation Anchor is designed to reattach tissue to bone in foot and ankle procedures. Seaview ...
Tags: FDA, 510(K)approval, KFx Medical's AppianFx Anchor, implants
LDR has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avenue L Lateral Lumber Cage system, which is implanted via a direct lateral trans-psoatic approach for lateral lumbar fusion. Avenue Lumber Cage ...
Tags: LDR, 510(k)approval, FDA, Avenue Lumber Cage system, lateral lumbar fusion