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Page 36 of 50 Pages |
Firms Should Perform Early Safety Testing on Nanotech Products FDAnews
- Saturday, October 14, 2006 Firms should make safety research on nanoparticles a priority in their product design processes, because the FDA’s limited resources do not allow the agency to fully research the potential safety risks of nanotechnology, experts say (see related
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FDA Wants Injunction Against Devicemaker for Illegal Distribution FDAnews
- Saturday, October 14, 2006 The FDA announced Oct. 6 it is seeking a permanent injunction against Endotec for its illegal distribution of total joint replacement devices. Endotec has continued to distribute the devices despite warnings that it was breaking federal law, the agency
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Tips for Firms Responding To FDA Inspections FDAnews
- Saturday, October 14, 2006 A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer told D&DL (see related
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Briefs FDAnews
- Saturday, October 14, 2006 ... more
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FDA ISSUES DETAILED REQUIREMENTS FOR DEVICE REPROCESSORS FDAnews
- Saturday, October 14, 2006 Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent
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GUIDANT WINS AGAIN IN MEDTRONIC PATENT LAWSUIT FDAnews
- Saturday, October 14, 2006 Boston Scientific announced Oct. 12 that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against
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BOVIE MEDICAL ANNOUNCES FDA CLEARANCE TO MARKET NEW LAPAROSCOPIC INSTRUMENTS FDAnews
- Saturday, October 14, 2006 Bovie Medical, a manufacturer and marketer of electrosurgical products, announced Oct. 12 it received FDA 510(k) clearance to market a new line of patent-pending advanced modular laparoscopic electrosurgical electrodes and a handle, aimed at the laparoscopic and arthroscopic
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DIAGNOSTIC ULTRASOUND CHANGES NAME TO VERATHON FDAnews
- Saturday, October 14, 2006 Diagnostic Ultrasound said it's changing its name to Verathon because it now sells products that aren't ultrasound
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RESEARCHERS DEVELOPING OFFICE-BASED CANCER SCREENING TEST FDAnews
- Saturday, October 14, 2006 Patients go to see their doctors for answers, but when it comes to cancer, physicians admit they need better tests to detect the earliest
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HOSPITAL PHONE BAN 'UNNECESSARY' FDAnews
- Saturday, October 14, 2006 Hospital restrictions on mobile phones are based largely on mythical safety risks and should be lifted, experts write in the British Medical
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REPORT: BOSTON SCIENTIFIC TAKING SALES HIT FROM STENT WORRIES FDAnews
- Saturday, October 14, 2006 A new report says Boston Scientific is losing sales due to doctor concerns over the risks posed by drug-coated heart
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EPOCAL RECEIVES FDA APPROVAL TO MARKET THE EPOCTM BLOOD ANALYSIS SYSTEM FDAnews
- Saturday, October 14, 2006 Epocal is pleased to announce receipt of 510(k) clearance from the US Food and Drug Administration to market its first product ? the EPOCTM Enterprise Point of Care Blood Analysis System ? in the United
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BOSTON SCIENTIFIC TO SELL BOVIE DEVICE FDAnews
- Saturday, October 14, 2006 Bovie Medical, a maker of electrosurgical products, said Wednesday it entered an agreement to make a device that will be distributed and sold by Boston Scientific
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FEC Ratifies Maritime Boundary With Benin, Approves 1,335 Megawatts Gas Turbine Plant, Others allAfrica.com
- Friday, October 13, 2006 Federal Executive Council on October 4 ratified the treaty between Nigeria and Benin Republic signed in August 2005, which extends Nigeria's maritime boundaries beyond 200 nautical
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Vigilance helps avoid common swindles Topix
- Wednesday, October 11, 2006 Pleasanton resident Debbie Ayers got scammed on Craigslist while looking for a roommate. Comment
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FEC Ratifies New Maritime Boundary With Benin Republic, Approves 2 Gas Turbine Plants, Others allAfrica.com
- Tuesday, October 10, 2006 The Federal Executive Council (FEC) has ratified a treaty between Nigeria and Benin Republic, which extends Nigeria's maritime boundaries beyond 200 nautical
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DEVICEMAKERS NEED TO ENSURE THEIR PRODUCTS AREN'T 'REUSED AGAINST THEM' FDAnews
- Tuesday, October 10, 2006 If device reprocessors had more legal responsibility for adverse events linked to reused single-use devices (SUDs), the original devicemakers would not have to worry so much about liability when problems arise with the reused devices, an expert
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FDA SEEKS INJUNCTION AGAINST ORTHOPEDIC DEVICEMAKER FDAnews
- Tuesday, October 10, 2006 The FDA is seeking a permanent injunction against Endotec and three of its executives to stop their illegal distribution of unapproved total-joint replacement devices, the agency announced Oct.
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Full Issue in PDF Format FDAnews
- Saturday, October 07, 2006 View the entire issue in PDF
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Devicemakers Need to Ensure Their Products Aren’t ‘Reused Against Them’ FDAnews
- Saturday, October 07, 2006 If device reprocessors had more legal responsibility for adverse events linked to reused single-use devices (SUDs), the originaldevicemakers would not have to worry so much about liability when problems arise with the reused devices, an expert
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