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U.S. Department of Health and Human Services

Medical Device Recalls

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Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway S... 3 05/31/2006 Medtronic Inc. Cardiac Rhythm Managment
Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability h... 2 07/13/2006 Aksys, Ltd.
DeVilbiss iFill Personal Oxygen Station model number 535D. 3 10/17/2006 Sunrise Medical
The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of seve... 2 09/25/2007 Philips Nuclear Medicine, Inc.
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulv... 2 01/23/2009 INGfertility, LLC
ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. ... 2 07/15/2009 Conformis Inc
ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. ... 2 07/15/2009 Conformis Inc
ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M5722060002... 2 07/15/2009 Conformis Inc
ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Pe... 2 08/27/2009 Memphis Fertility Laboratory Inc
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. 2 11/25/2009 Philips Lifeline Inc
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