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Journal Abstract Search
414 related items for PubMed ID: 26984921
1. Analysis of FDA-Approved Orthopaedic Devices and Their Recalls. Day CS, Park DJ, Rozenshteyn FS, Owusu-Sarpong N, Gonzalez A. J Bone Joint Surg Am; 2016 Mar 16; 98(6):517-24. PubMed ID: 26984921 [Abstract] [Full Text] [Related]
2. 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 16; 474(4):1053-68. PubMed ID: 26584802 [Abstract] [Full Text] [Related]
4. 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]
5. 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]
8. Medical device recalls and the FDA approval process. Zuckerman DM, Brown P, Nissen SE. Arch Intern Med; 2011 Jun 13; 171(11):1006-11. PubMed ID: 21321283 [Abstract] [Full Text] [Related]
9. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015. Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Ophthalmology; 2017 Aug 13; 124(8):1237-1246. PubMed ID: 28501378 [Abstract] [Full Text] [Related]
10. Assessment of cardiovascular and noncardiovascular medical device recalls. Somberg JC, McEwen P, Molnar J. Am J Cardiol; 2014 Jun 01; 113(11):1899-903. PubMed ID: 24837271 [Abstract] [Full Text] [Related]
11. Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety. Janetos TM, Ghobadi CW, Xu S, Walter JR. Am J Obstet Gynecol; 2017 Jul 01; 217(1):42-46.e1. PubMed ID: 28500861 [Abstract] [Full Text] [Related]
12. 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 01; 17(1):150-157. PubMed ID: 27737804 [Abstract] [Full Text] [Related]
14. Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process. Pellerin C, Adamson M, Janney C. Cureus; 2020 Aug 14; 12(8):e9744. PubMed ID: 32944459 [Abstract] [Full Text] [Related]
15. Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health. Ronquillo JG, Zuckerman DM. Milbank Q; 2017 Sep 14; 95(3):535-553. PubMed ID: 28895231 [Abstract] [Full Text] [Related]
16. Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. Everhart AO, Sen S, Stern AD, Zhu Y, Karaca-Mandic P. JAMA; 2023 Jan 10; 329(2):144-156. PubMed ID: 36625811 [Abstract] [Full Text] [Related]
17. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. Rome BN, Kramer DB, Kesselheim AS. JAMA; 2023 Jan 10; 311(4):385-91. PubMed ID: 24449317 [Abstract] [Full Text] [Related]