Search Results for 'clearance'
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Patient Monitoring
IRADIMED Corporation Announces 510(k) Clearance of Invasive Blood Pressure Module
Product is designed for use with the company's MRI-compatible patient vital signs monitor.Globe Newswire 02.05.19
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TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System
Company receives clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy procedures.Business Wire 07.10.18
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Mauna Kea Obtains FDA Clearance for Applications of Cellvizio Confocal Laser Endomicroscopy
Product provides unique response to unmet needs during brain and spinal surgeries.Business Wire 07.09.18
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Contrast Clearance Analysis Software Receives FDA 510(k) Clearance
Scientists evaluate MR-based technology for differentiating treatment effects.Businesswire 01.05.18
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Cardiovascular
Avinger Receives 510(k) Clearance for Design Modifications to Pantheris Atherectomy Device
Updates to first-ever image-guided atherectomy device designed to improve efficiency.Avinger Inc. 11.15.17
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Crospon Receives 510(k) FDA Clearance for Endoflip with Flip Topography Module
System will greatly improve the quality of patient experience during swallow testing.Business Wire 05.19.17
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Research Shows New Active Drain Line Clearance System Improves Data Accuracy
Accuryn has potential to guide more precise fluid therapy for burn patients, resulting in better care and lower mortality.Business Wire 05.05.17
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Surgical
Scopis Receives FDA 510(K), Health Canada MDL Clearance for Surgical Navigation System
Company also hires vice president of sales for North America.Business Wire 03.09.17
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Polyganics Receives FDA 510(k) Clearance for Nerve Capping Device
Product is designed to reduce neuroma formation and facilitate tissue repair.Polyganics 01.27.16
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Materials
Promoting Medical Devices Prior to FDA Approval or Clearance
Promoting Medical Devices Prior to FDA Approval or Clearance James R. Ravitz, Arent Fox PLLC Earlier this year, this column examined the FDA’s regulations and trends with respect to direct-to-consumer advertising. Now we’ll exam…James R. Ravitz 10.21.06
