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Steris Corporation.(MEDICAL DEVICES)
- Article from:
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Warning Letter Bulletin
- Article date:
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June 1, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Mentor, OH, May 15 (Cincinnati District)
Leading medical device sterilizer firm Steris received a warning letter concerning a variety of GMP and pre-market approval violations, including making changes to software without 510(k)s.
Following a review of company records involving its System 1 Processor (SS1), including the Sterilant 20, which is a liquid chemical sterilizer used to clean instruments such as endoscopes and bronchoscopes, FDA deemed the products adulterated for failing to have a PMA or IDE.
The agency also deemed the device misbranded because Steris did not notify the agency of its intent to introduce the device into commercial distribution.
The ...
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Georgia, South Carolina Inventors Develop Erectile Dysfunction Treatment...
US Fed News Service, Including US State News;
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315 words
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Finishing Today;
February 1, 2007 ;
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Garage tools stolen.(News)
South Wales Echo (Cardiff, Wales);
December 18, 2001 ;
26 words
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Editor's Spotlight: Pumps: Sanitary High Pressure Pump.
Food Manufacturing;
September 1, 2001 ;
89 words
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Ink Maker;
December 1, 2005 ;
92 words
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Sanitary high pressure pump. (Pumps).(advertisement)
Food Manufacturing;
April 1, 2002 ;
93 words
......ideal for a variety of high pressure pumping applications. Based upon the field-proven 2000 Pump drive end, the Sanitary High Pressure Pump is capable of generating a maximum flow rate of 225 GPM and a maximum pressure of 600 PSI. End users no longer have to deal...
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Japanese Inventors Develop Fluid High Pressure Pump
US Fed News Service, Including US State News;
November 3, 2007 ;
306 words
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High-pressure pump.(Brief Article)(Product Announcement)
Chemistry and Industry;
October 16, 2000 ;
57 words
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Indiana Inventor Develops Marine Vapor Separator with Bypass Line
US Fed News Service, Including US State News;
February 5, 2007 ;
376 words
......fuel are collected and vented. A high pressure pump withdraws liquid fuel from the vapor...The fuel pressure between the high pressure pump and the engine injector system is monitored...needed is being supplied by the high pressure pump, the unneeded fuel is returned to the...
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Japanese Inventors Develop High-Pressure Pump
US Fed News Service, Including US State News;
October 20, 2006 ;
292 words
......and Hiroshi Inoue of Chiryu, Japan, have developed a high pressure pump for preventing distortion of a sealing surface or a cylinder...According to the U.S. Patent & Trademark Office: "The high pressure pump has an intermediate member including a cylinder body having...
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Japanese Inventors Develop High-Pressure Fuel Pump
US Fed News Service, Including US State News;
October 3, 2006 ;
307 words
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Fluid power: valve. (Product News).
Global Design News;
October 1, 2001 ;
78 words
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