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Journal Abstract Search

414 related items for PubMed ID: 26984921

  • 21. Orbital Implants Receiving Food and Drug Administration Premarket Notification.
    Corcoran Ruiz KM, Vaishnav YJ, Desautels J, Schaefer JL, Migliori ME, Yilmaz T.
    Ophthalmic Plast Reconstr Surg; ; 38(5):503-506. PubMed ID: 35699217
    [Abstract] [Full Text] [Related]

  • 22. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.
    Kadakia KT, Dhruva SS, Caraballo C, Ross JS, Krumholz HM.
    JAMA; 2023 Jan 10; 329(2):136-143. PubMed ID: 36625810
    [Abstract] [Full Text] [Related]

  • 23. Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories.
    Ghobadi CW, Janetos TM, Tsai S, Welty L, Walter JR, Xu S.
    Issues Law Med; 2019 Jan 10; 34(1):77-92. PubMed ID: 31179672
    [Abstract] [Full Text] [Related]

  • 24. Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.
    Connor MJ, Tringale K, Moiseenko V, Marshall DC, Moore K, Cervino L, Atwood T, Brown D, Mundt AJ, Pawlicki T, Recht A, Hattangadi-Gluth JA.
    Int J Radiat Oncol Biol Phys; 2017 Jun 01; 98(2):438-446. PubMed ID: 28463163
    [Abstract] [Full Text] [Related]

  • 25. 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 Jun 01; 19(3):173-84. PubMed ID: 20939777
    [Abstract] [Full Text] [Related]

  • 26. Pediatric Device Innovation: An Analysis of Food and Drug Administration Authorizations Over Time.
    Dubin J, Sardesai K, Grote C, Tougas C, Branche K, Otsuka N.
    J Bone Joint Surg Am; 2024 Sep 04; 106(17):1594-1599. PubMed ID: 38838107
    [Abstract] [Full Text] [Related]

  • 27. 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]

  • 28. Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015.
    Ghobadi CW, Hayman EL, Xu S.
    J Am Coll Radiol; 2016 Jun 24; 13(6):638-43. PubMed ID: 26922597
    [Abstract] [Full Text] [Related]

  • 29. US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.
    Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST.
    Otolaryngol Head Neck Surg; 2017 Oct 24; 157(4):608-617. PubMed ID: 28786317
    [Abstract] [Full Text] [Related]

  • 30. Major FDA medical device recalls in ophthalmology from 2003 to 2015.
    Talati RK, Gupta AS, Xu S, Ghobadi CW.
    Can J Ophthalmol; 2018 Apr 24; 53(2):98-103. PubMed ID: 29631834
    [Abstract] [Full Text] [Related]

  • 31. The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.
    Dubin JR, Ibad H, Cil A, Murray M.
    J Am Acad Orthop Surg; 2022 Jul 15; 30(14):658-667. PubMed ID: 35797679
    [Abstract] [Full Text] [Related]

  • 32. Recalls and Premarket Review Systems for High-Risk Medical Devices in Japan.
    Nakayama M, Tanaka S, Hamada S, Uchida T, Kawakami K.
    Ther Innov Regul Sci; 2019 Nov 15; 53(6):775-780. PubMed ID: 30526015
    [Abstract] [Full Text] [Related]

  • 33. Cardiac device creativity and innovation under constraints: Exploring trends from the food and drug administration's device clearances and recalls.
    Cremers T, Kashem A, Zhao H, Toyoda Y, Mokashi S.
    Curr Probl Cardiol; 2024 Nov 15; 49(11):102781. PubMed ID: 39127432
    [Abstract] [Full Text] [Related]

  • 34. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Apr 12; 65(71):19650-8. PubMed ID: 11010632
    [Abstract] [Full Text] [Related]

  • 35. An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.
    Pellerin C, Panchbhavi V, Janney CF.
    Cureus; 2018 Aug 09; 10(8):e3123. PubMed ID: 30338198
    [Abstract] [Full Text] [Related]

  • 36. Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.
    Ezaldein HH, Hill ST, Merati M, Suggs A, Reichert B, Scott JF.
    Lasers Surg Med; 2020 Nov 09; 52(9):837-841. PubMed ID: 32221981
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  • 37. Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.
    Dubin JR, Enriquez JR, Cheng AL, Campbell H, Cil A.
    JAMA Netw Open; 2023 Apr 03; 6(4):e237699. PubMed ID: 37043202
    [Abstract] [Full Text] [Related]

  • 38. 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 03; 174(11):1773-9. PubMed ID: 25265209
    [Abstract] [Full Text] [Related]

  • 39. 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 15; 29(24):e1362-e1369. PubMed ID: 34161960
    [Abstract] [Full Text] [Related]

  • 40. Risk of Recall for Total Joint Arthroplasty Devices Over 10 Years.
    DeRuyter MT, Mansy LN, Krumme JW, Cheng AL, Dubin JR, Cil A.
    J Arthroplasty; 2023 Aug 15; 38(8):1444-1448. PubMed ID: 36773660
    [Abstract] [Full Text] [Related]

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