Review of approvals and recalls of US specific medical devices in general and plastic surgery

Author:

Shah AashkaORCID,Olson Michelle M.,Maurice Joseph M.

Publisher

Elsevier BV

Subject

Organic Chemistry,Biochemistry

Reference37 articles.

1. FDA Approval vs. FDA Clearance: What Are the Differences? GoodRx. Accessed September 18, 2022. https://www.goodrx.com/healthcare-access/medication-education/fda-approval-vs-fda-clearance.

2. Horwitz R. The Dalkon Shield | The Embryo Project Encyclopedia. The dalkon shield. Published January 10, 2018. Accessed December 16, 2021. https://embryo.asu.edu/pages/dalkon-shield.

3. FDA device oversight from 1906 to the present;Pisac;AMA J Ethics,2021

4. U.S. Food & Drug Administration. DeRoyal Industries, Inc. recalls procedure packs containing Smiths Medical NORMOFLO irrigation warming set due to the possibility of harmful levels of aluminum leaching into the fluid path of the warmers. Available at: https://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-inc-recalls-procedure-packs-containing-smiths-medical-normoflo-irrigation-warming. Accessed July 12, 2022.

5. Health C for D and R. Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders. U.S. Food and Drug Administration. Published June 1, 2020. Accessed September 18, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders.

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