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Class I Medical Device Recall: Maquet Medical Systems, Tiger Paw System II
Recall Class: Class I Date Recall Initiated: March 25, 2015 Device: TigerPaw System II All Lots Part and Serial Numbers: C-TP-1507 (7 connectors) C-TP-1509 (9 connectors) Distribution Dates: April 1, 2013 through March 23, 2015 Number of Units Distributed in the U.S. 4,154 U.S. Distribution: 223 Customers Use: The TigerPaw II is a surgical staple used to close…
24 Hour Summary posted for April 30
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN130047, DEN130004, DEN120017 and DEN100024 added)
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Meeting Materials posted for May 14-15, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
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Launch of AccessGUDID
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Presentations posted for April 30
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Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication
Date Issued: April 30, 2015 Audience: Patients who had mammograms at Coastal Diagnostic Center located in Pismo Beach, California any time on or after February 24, 2013. Health care providers who have referred patients to Coastal Diagnostic Center for a mammogram performed any time on or after February 24, 2013. Medical Specialty: Primary Care, Family…
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
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Summary Information for: KAMRA Inlay
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