These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
107 related articles for article (PubMed ID: 35438741)
21. Medical device immunity: should promotion of off-label uses leave medical device manufacturers vulnerable to unlimited liability? Palmer PG J Leg Med; 2014; 35(4):553-77. PubMed ID: 25517635 [No Abstract] [Full Text] [Related]
22. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. Reynolds IS; Rising JP; Coukell AJ; Paulson KH; Redberg RF JAMA Intern Med; 2014 Nov; 174(11):1773-9. PubMed ID: 25265209 [TBL] [Abstract][Full Text] [Related]
23. Software-related recalls: an analysis of records. Simone LK Biomed Instrum Technol; 2013; 47(6):514-22. PubMed ID: 24328977 [TBL] [Abstract][Full Text] [Related]
24. 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; 314(6):604-12. PubMed ID: 26262798 [TBL] [Abstract][Full Text] [Related]
25. How does medical device regulation perform in the United States and the European union? A systematic review. Kramer DB; Xu S; Kesselheim AS PLoS Med; 2012; 9(7):e1001276. PubMed ID: 22912563 [TBL] [Abstract][Full Text] [Related]
26. Medical devices; medical device user facility and manufacturer reporting, certification and registration; Office of Management and Budget approval; extension of effective date--FDA. Final rule; notification of approval of information collection requirements. Fed Regist; 1996 Apr; 61(71):16043-5. PubMed ID: 10157704 [No Abstract] [Full Text] [Related]
27. Medical device recalls and the FDA approval process. Zuckerman DM; Brown P; Nissen SE Arch Intern Med; 2011 Jun; 171(11):1006-11. PubMed ID: 21321283 [TBL] [Abstract][Full Text] [Related]
28. Medical device regulation in Australia: safe and effective? McGee RG; Webster AC; Rogerson TE; Craig JC Med J Aust; 2012 Mar; 196(4):256-60. PubMed ID: 22409692 [TBL] [Abstract][Full Text] [Related]
29. FDA regulation of cardiovascular devices and opportunities for improvement. Dhruva SS; Redberg RF J Interv Card Electrophysiol; 2013 Mar; 36(2):99-105. PubMed ID: 23263896 [TBL] [Abstract][Full Text] [Related]
30. Medical device recalls. Spencer P; Zakaib GM Health Law Can; 2001 Aug; 22(1):1-4. PubMed ID: 11550586 [No Abstract] [Full Text] [Related]
31. [The EU medical device market process and enlightenment for the review]. Luo Q Zhongguo Yi Liao Qi Xie Za Zhi; 2014 May; 38(3):210-2. PubMed ID: 25241519 [TBL] [Abstract][Full Text] [Related]
32. The role of the U.S. Food and Drug Administration in device evaluation and monitoring. ; Diehl DL; Tierney WM; Adler DG; Conway JD; Farraye FA; Kantsevoy SV; Kaul V; Kethu SR; Kwon RS; Mamula P; Pedrosa MC; Rodriguez SA Gastrointest Endosc; 2010 Jul; 72(1):5-10. PubMed ID: 20421100 [TBL] [Abstract][Full Text] [Related]
33. [Development and Application of Medical Device Recall Event Tracking System]. Zhu J; Lou X; Zhang J; Sun Y Zhongguo Yi Liao Qi Xie Za Zhi; 2022 Sep; 46(5):545-549. PubMed ID: 36254484 [TBL] [Abstract][Full Text] [Related]
34. Medical Device Manufacturing and Medical Device Reports (MDR). Arellano V Insight; 2009; 34(3):24-5. PubMed ID: 19708431 [No Abstract] [Full Text] [Related]
35. The Interconnected Ancestral Network of Hip Arthroplasty Device Approval. Premkumar A; Zhu A; Ying X; Pean CA; Sheth NP; Cross MB; Gonzalez Della Valle A J Am Acad Orthop Surg; 2021 Dec; 29(24):e1362-e1369. PubMed ID: 34161960 [TBL] [Abstract][Full Text] [Related]
36. [The maze of the clinical evaluation reports]. Rule C Ann Biol Clin (Paris); 2015; 73(6):637-8. PubMed ID: 26635044 [No Abstract] [Full Text] [Related]
38. Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra. Kadakia KT; Beckman AL; Ross JS; Krumholz HM JAMA Intern Med; 2022 Jan; 182(1):59-65. PubMed ID: 34842892 [TBL] [Abstract][Full Text] [Related]
39. New orthopedic devices and the FDA. Sheth U; Nguyen NA; Gaines S; Bhandari M; Mehlman CT; Klein G J Long Term Eff Med Implants; 2009; 19(3):173-84. PubMed ID: 20939777 [TBL] [Abstract][Full Text] [Related]
40. Management of recalled pacemakers and defibrillators. Cavagna M; Strickberger SA Expert Rev Cardiovasc Ther; 2006 Sep; 4(5):601-3. PubMed ID: 17081081 [No Abstract] [Full Text] [Related] [Previous] [Next] [New Search]