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Volumn 113, Issue 11, 2014, Pages 1899-1903

Assessment of cardiovascular and noncardiovascular medical device recalls

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVASCULAR EQUIPMENT; DEVICE APPROVAL; DEVICE RECALL; DEVICE SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; MANDATORY TESTING; MARKETING; MEDICAL DEVICE REGULATION; PRIORITY JOURNAL; RISK FACTOR; UNITED STATES; WEB BROWSER;

EID: 84900867105     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2014.03.024     Document Type: Article
Times cited : (18)

References (16)
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    • (2012) FDA Regulation of Medical Devices
    • Johnson, J.A.1
  • 3
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    • Zuckerman, D.M.1    Brown, P.2    Nissen, S.E.3
  • 4
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    • Postmarketing surveillance of medical devices - Filling in the gaps
    • F.S. Resnic, and S.L. Normand Postmarketing surveillance of medical devices - filling in the gaps N Engl J Med 366 2012 875 877
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    • Resnic, F.S.1    Normand, S.L.2
  • 5
    • 84857886806 scopus 로고    scopus 로고
    • Here we go again - Failure of postmarketing device surveillance
    • R.G. Hauser Here we go again - failure of postmarketing device surveillance N Engl J Med 366 2012 873 875
    • (2012) N Engl J Med , vol.366 , pp. 873-875
    • Hauser, R.G.1
  • 6
    • 84872082045 scopus 로고    scopus 로고
    • The 510(k) ancestry of a metal-on-metal hip implant
    • B.M. Ardaugh, S.E. Graves, and R.F. Redberg The 510(k) ancestry of a metal-on-metal hip implant N Engl J Med 368 2013 97 100
    • (2013) N Engl J Med , vol.368 , pp. 97-100
    • Ardaugh, B.M.1    Graves, S.E.2    Redberg, R.F.3
  • 7
    • 80052863459 scopus 로고    scopus 로고
    • Medical devices - Balancing regulation and innovation
    • G.D. Curfman, and R.F. Redberg Medical devices - balancing regulation and innovation N Engl J Med 365 2011 975 977
    • (2011) N Engl J Med , vol.365 , pp. 975-977
    • Curfman, G.D.1    Redberg, R.F.2
  • 9
    • 80052844540 scopus 로고    scopus 로고
    • Medical devices and health - Creating a new regulatory framework for moderate-risk devices
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    • (2011) N Engl J Med , vol.365 , pp. 977-979
    • Challoner, D.R.1    Vodra, W.W.2
  • 10
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    • Institute of Medicine National Academies Press Washington, DC (Last accessed on February 11, 2014 at
    • Institute of Medicine Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years 2011 National Academies Press Washington, DC 1 206 (Last accessed on February 11, 2014 at http://www.iom.edu/Reports/2011/ Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35- Years.aspx
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  • 12
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  • 13
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  • 14
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    • US Food and Drug Administration (Last accessed on February 11, 2014 at)
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  • 15
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    • Medical and Radiation-Emitting Recalls


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.