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PUBMED FOR HANDHELDS

Journal Abstract Search

288 related items for PubMed ID: 27737804

  • 1. Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices.
    Golish SR, Reed ML.
    Spine J; 2017 Jan; 17(1):150-157. PubMed ID: 27737804
    [Abstract] [Full Text] [Related]

  • 2. Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs.
    Golish SR.
    Trials; 2017 Jul 24; 18(1):348. PubMed ID: 28738891
    [Abstract] [Full Text] [Related]

  • 3. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
    Samuel AM, Rathi VK, Grauer JN, Ross JS.
    Clin Orthop Relat Res; 2016 Apr 24; 474(4):1053-68. PubMed ID: 26584802
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  • 8. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
    Rome BN, Kramer DB, Kesselheim AS.
    JAMA; 2016 Apr 24; 311(4):385-91. PubMed ID: 24449317
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  • 9. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
    Rathi VK, Krumholz HM, Masoudi FA, Ross JS.
    JAMA; 2015 Aug 11; 314(6):604-12. PubMed ID: 26262798
    [Abstract] [Full Text] [Related]

  • 10. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.
    Dubin JR, Simon SD, Norrell K, Perera J, Gowen J, Cil A.
    JAMA Netw Open; 2021 May 03; 4(5):e217274. PubMed ID: 33956132
    [Abstract] [Full Text] [Related]

  • 11. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.
    Steinvil A, Rogers T, Torguson R, Waksman R.
    JACC Cardiovasc Interv; 2016 Sep 12; 9(17):1757-64. PubMed ID: 27609249
    [Abstract] [Full Text] [Related]

  • 12. Orthopedic devices; reclassification of the intervertebral body fusion device. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2007 Jun 12; 72(112):32170-2. PubMed ID: 17632942
    [Abstract] [Full Text] [Related]

  • 13. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?
    Fox-Rawlings SR, Gottschalk LB, Doamekpor LA, Zuckerman DM.
    Milbank Q; 2018 Sep 12; 96(3):499-529. PubMed ID: 30203600
    [Abstract] [Full Text] [Related]

  • 14. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.
    Yang BW, Iorio ML, Day CS.
    J Bone Joint Surg Am; 2017 Mar 15; 99(6):e26. PubMed ID: 28291189
    [Abstract] [Full Text] [Related]

  • 15. Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017.
    Peters W, Pellerin C, Janney C.
    Biomed Instrum Technol; 2020 Nov 01; 54(6):418-426. PubMed ID: 33339030
    [Abstract] [Full Text] [Related]

  • 16. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
    Chang L, Dhruva SS, Chu J, Bero LA, Redberg RF.
    BMJ; 2015 Jun 10; 350():h2613. PubMed ID: 26063311
    [Abstract] [Full Text] [Related]

  • 17. Postmarketing trials and pediatric device approvals.
    Hwang TJ, Kesselheim AS, Bourgeois FT.
    Pediatrics; 2014 May 10; 133(5):e1197-202. PubMed ID: 24733871
    [Abstract] [Full Text] [Related]

  • 18. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.
    Swanson MJ, Johnston JL, Ross JS.
    Trials; 2021 Nov 17; 22(1):817. PubMed ID: 34789308
    [Abstract] [Full Text] [Related]

  • 19. Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2004 Oct 04; 69(191):59132-4. PubMed ID: 15460583
    [Abstract] [Full Text] [Related]

  • 20. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.
    Zheng SY, Dhruva SS, Redberg RF.
    JAMA; 2017 Aug 15; 318(7):619-625. PubMed ID: 28810022
    [Abstract] [Full Text] [Related]

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