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Items: 1 to 20 of 305

1.

Medical device recalls and the FDA approval process.

Zuckerman DM, Brown P, Nissen SE.

Arch Intern Med. 2011 Jun 13;171(11):1006-11. doi: 10.1001/archinternmed.2011.30. Epub 2011 Feb 14.

PMID:
21321283
2.

Assessment of cardiovascular and noncardiovascular medical device recalls.

Somberg JC, McEwen P, Molnar J.

Am J Cardiol. 2014 Jun 1;113(11):1899-903. doi: 10.1016/j.amjcard.2014.03.024. Epub 2014 Mar 17.

PMID:
24837271
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;474(4):1053-68. doi: 10.1007/s11999-015-4634-x. Epub 2015 Nov 19.

4.

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. doi: 10.2106/JBJS.15.00286. Review.

PMID:
26984921
5.

Medical device recalls: get it right the first time: Comment on "Medical device recalls and the FDA approval process".

Redberg RF, Dhruva SS.

Arch Intern Med. 2011 Jun 13;171(11):1011-2. doi: 10.1001/archinternmed.2011.27. Epub 2011 Feb 14. No abstract available.

PMID:
21321286
6.

FDA medical device approval: things you didn't learn in medical school or residency.

Buch B.

Am J Orthop (Belle Mead NJ). 2007 Aug;36(8):407-12.

PMID:
17849025
7.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Rome BN, Kramer DB, Kesselheim AS.

JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986.

8.

FDA recalls not as alarming as they seem.

Connor JT, Lewis RJ, Berry DA, Berry SM.

Arch Intern Med. 2011 Jun 13;171(11):1044-5; author reply 1045-6. doi: 10.1001/archinternmed.2011.242. No abstract available.

PMID:
21670380
10.

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.

PMID:
20939777
11.

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.

IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. Review.

PMID:
17894274
12.

Off-label use of medical devices in radiology: regulatory standards and recent developments.

Smith JJ.

J Am Coll Radiol. 2010;7(2):115-9. doi: 10.1016/j.jacr.2009.09.025.

PMID:
20142085
14.

Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.

Dhruva SS, Bero LA, Redberg RF.

Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):165-71. doi: 10.1161/CIRCOUTCOMES.110.958215. Epub 2011 Mar 1. Review.

15.

US Congress considers new tracking system for medical devices after excessive recalls.

Epstein K.

BMJ. 2012 Apr 23;344:e2915. doi: 10.1136/bmj.e2915. No abstract available.

PMID:
22529316
16.
17.

Health device legislation: an overview of the law and its impact on respiratory care.

Bancroft ML, Steen JA.

Respir Care. 1978 Dec;23(12):1179-84.

PMID:
10315033
18.

FDA regulation of cardiovascular devices and opportunities for improvement.

Dhruva SS, Redberg RF.

J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

PMID:
23263896
19.

In the hot seat. Study questions FDA's fast-track process.

McKinney M.

Mod Healthc. 2011 Feb 21;41(8):16. No abstract available.

PMID:
21608192

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