Search Results for 'clearance'
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Innovative Health Receives FDA Clearance to Reprocess the Webster Duo-Decapolar EP Catheter
Decision marks the company's fifth EP reprocessing clearance this year.Innovative Health 08.26.19
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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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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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Cardiovascular
FlowAid Receives FDA Clearance for the FA100 SCCD
The device is used for the treatment of diseases and discomforts that can be relieved by increased blood flow.Business Wire 02.24.17
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R&D & Design
QT Vascular Receives FDA 510(k) Clearance for Chocolate XD PTCA Balloon
The Chocolate XD PTCA balloon was approved for use in coronary interventions.PR Newswire 06.28.16
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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
