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Products and Medical Procedures | FDA

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Devices</a> </li> <li > <a class="current-link">Products and Medical Procedures</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/medical-devices" title="Medical Devices"> Medical Devices </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Products and Medical Procedures</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fmedical-devices%2Fproducts-and-medical-procedures" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Products%20and%20Medical%20Procedures&amp;url=https://www.fda.gov%2Fmedical-devices%2Fproducts-and-medical-procedures" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&amp;url=https://www.fda.gov%2Fmedical-devices%2Fproducts-and-medical-procedures&amp;title=Products%20and%20Medical%20Procedures&amp;source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Products%20and%20Medical%20Procedures&amp;body=https://www.fda.gov%2Fmedical-devices%2Fproducts-and-medical-procedures" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>The FDA regulates medical devices sold in the United States to assure their safety and effectiveness.</p> <p>Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. Our <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm">Medical Device Product Classification database</a> lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type.</p> <p>Depending on the device classification, along with other factors, federal regulations (such as the&nbsp;<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm">Code of Federal Regulations, Title 21</a>)&nbsp;define requirements that must be fulfilled for CDRH to approve or clear devices&nbsp;sold in the United States.</p> <br> <div class="field field--name-field-sub-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Sub-Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >Medical Device Approvals and Clearances</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/device-approvals-and-clearances/recently-approved-devices">Recently-Approved Devices</a></h3> <p class="lcds-card__text">Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/device-approvals-and-clearances/510k-clearances">510(k) Premarket Notification Clearances</a></h3> <p class="lcds-card__text">Find out which devices have been cleared recently through the 510(k) review process or search the 510(k) Premarket Notification database.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/device-approvals-and-clearances/pma-approvals">Premarket Approvals (PMA) for Class III Devices</a></h3> <p class="lcds-card__text">Find out which devices have been approved recently through the PMA review process or search the Premarket Approval (PMA) database.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/device-approvals-and-clearances/hde-approvals">Humanitarian Device Exception (HDE) Approvals</a></h3> <p class="lcds-card__text">See which devices have been approved through the Humanitarian Device Exception (HDE) review process.</p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >I&#039;m looking for information on...</h2> </header> <div class="lcds-card-deck__body"> <a href="/medical-devices/implants-and-prosthetics/breast-implants" title="Breast Implants"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/implant9884.jpg?itok=Fmkvn1CA 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/implant9884.jpg?itok=Fmkvn1CA 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/implant9884.jpg?itok=RXuUY99B 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/implant9884.jpg?itok=RXuUY99B 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/implant9884.jpg?itok=RXuUY99B 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/implant9884.jpg?itok=RXuUY99B 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/implant9884.jpg?itok=RXuUY99B" width="420" height="220" alt="Photograph of a woman holding a breast implant" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Breast Implants</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/consumer-products/contact-lenses" title="Contact Lenses"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/contactlenseonfingertip.jpg?itok=ntXRdJ8v 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/contactlenseonfingertip.jpg?itok=ntXRdJ8v 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/contactlenseonfingertip.jpg?itok=9M5YOn6l 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/contactlenseonfingertip.jpg?itok=9M5YOn6l 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/contactlenseonfingertip.jpg?itok=9M5YOn6l 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/contactlenseonfingertip.jpg?itok=9M5YOn6l 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/contactlenseonfingertip.jpg?itok=9M5YOn6l" width="420" height="220" alt="Contact Lens on fingertip" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Contact Lenses</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/products-and-medical-procedures/respiratory-devices" title="Respiratory Devices"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=TnHsmcGf 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=TnHsmcGf 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=rHiQbFTi 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=rHiQbFTi 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=rHiQbFTi 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=rHiQbFTi 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/man_using_CPAP_drupal_1600x900-01.png?itok=rHiQbFTi" width="420" height="220" alt="Man Using a CPAP Machine" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Respiratory Devices</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/consumer-products/hearing-aids" title="Hearing Aids"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=dFCzWqU6 380w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=dFCzWqU6 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=Ig5YoATS 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=Ig5YoATS 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=Ig5YoATS 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=Ig5YoATS 420w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/hearing-aids-variety-collage-1600x900_03.png?itok=Ig5YoATS" width="420" height="220" alt="Photo collage showing various hearing aids and personal sound amplification products in people&#039;s ears" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Hearing Aids</h3> <p class="lcds-card__text"></p> </div> </article> </a> </div> </section></div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >Medical Devices by Purpose</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/aesthetic-cosmetic-devices">Cosmetic Devices</a></h3> <p class="lcds-card__text">Devices used to improve appearance, such as dermal fillers (soft tissue fillers).</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/general-hospital-devices-and-supplies">General Hospital Devices and Supplies</a></h3> <p class="lcds-card__text">Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data systems (MDDS), and sterilization systems (liquid chemical, ethylene oxide).</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/home-health-and-consumer-devices">Home Health and Consumer Devices</a></h3> <p class="lcds-card__text">Devices that consumers use themselves, such as bed rails, breast pumps, contact lenses, hearing aids, sharps (needles and syringes), electronic muscle stimulators, and artificial pancreas device systems.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/implants-and-prosthetics">Implants and Prosthetics</a></h3> <p class="lcds-card__text">Devices or tissues that are placed inside or on the surface of the body, including breast implants, cochlear implants, mesh implants, phakic intraocular lenses, and cerebral spinal fluid (CSF) shunt systems.</p> </article> </div> </section> </div> <div class="field--item"> <section class="lcds-card-deck--promoted lcds-card-deck bg-lightest-gray"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >Special Topics in Medical Devices</h2> </header> <div class="lcds-card-deck__body"> <a href="/medical-devices/products-and-medical-procedures/3d-printing-medical-devices" title="3D Printing of Medical Devices"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/Examples-of-3D-printed-devices..jpg?itok=00UfSJ73 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/Examples-of-3D-printed-devices..jpg?itok=00UfSJ73 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/Examples-of-3D-printed-devices..jpg?itok=v62l1_a6 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Examples-of-3D-printed-devices..jpg?itok=v62l1_a6 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Examples-of-3D-printed-devices..jpg?itok=v62l1_a6 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Examples-of-3D-printed-devices..jpg?itok=v62l1_a6 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/Examples-of-3D-printed-devices..jpg?itok=v62l1_a6" width="420" height="220" alt="Examples of 3D printed devices" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">3D Printing of Medical Devices</h3> <p class="lcds-card__text"></p> </div> </article> </a> <a href="/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices" title="Reprocessing of Reusable Devices"> <article class="lcds-card lcds-card--promoted lcds-card--promoted-subtopic bg-white"> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/thunbnail_3/public/Endoscopes.jpg?itok=of3TDJuU 380w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/thunbnail_3/public/Endoscopes.jpg?itok=of3TDJuU 380w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="380" height="200"/> <source srcset="/files/styles/medium_3/public/Endoscopes.jpg?itok=8xaVy1tF 420w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Endoscopes.jpg?itok=8xaVy1tF 420w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Endoscopes.jpg?itok=8xaVy1tF 420w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <source srcset="/files/styles/medium_3/public/Endoscopes.jpg?itok=8xaVy1tF 420w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="420" height="220"/> <img loading="eager" src="/files/styles/medium_3/public/Endoscopes.jpg?itok=8xaVy1tF" width="420" height="220" alt="Reprocessing an endoscope" class="img-responsive" /> </picture> </div> </div> <div class="lcds-card__body"> <h3 class="lcds-card__title">Reprocessing of Reusable Devices</h3> <p class="lcds-card__text"></p> </div> </article> </a> </div> </section></div> <div class="field--item"> <section class="lcds-card-deck--teaser lcds-card-deck txt-dark"> <header class="lcds-card-deck__header"> <h2 class="lcds-card-deck__heading" >Medical Devices by Specialty</h2> </header> <div class="lcds-card-deck__body"> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/respiratory-devices">Respiratory Devices</a></h3> <p class="lcds-card__text">Devices used to help breathing, such as ventilators, BiPAP machines, and CPAP machines. </p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/consumer-products/hearing-aids">Hearing Aids</a></h3> <p class="lcds-card__text">Devices used to amplify sounds to help people who have hearing loss.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/pediatric-medical-devices">Pediatric Medical Devices</a></h3> <p class="lcds-card__text">Devices used to diagnose or treat diseases and conditions in newborns, infants, children, and adolescents through age 21.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/cardiovascular-devices">Cardiovascular Devices</a></h3> <p class="lcds-card__text">Devices used to diagnose and treat heart disease and related health problems, such as automated external defibrillators (AEDs) and heater-cooler devices.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/neurological-devices">Neurological Devices</a></h3> <p class="lcds-card__text">Devices used to diagnose, prevent, and treat neurological disorders and conditions, such as devices for assessing head injury.</p> </article> <article class="lcds-card lcds-card--border-top lcds-card--teaser lcds-card--teaser-subtopic"> <h3 class="lcds-card__title"><a href="/medical-devices/products-and-medical-procedures/dental-devices">Dental Devices</a></h3> <p class="lcds-card__text">Devices used to maintain dental health and treat dental problems, such as denture adhesives, dental amalgam, dental unit waterlines, and multiple-use dental dispenser devices (dental syringes).</p> </article> </div> </section> </div> </div> </div> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2023-10-05T04:21:00Z">10/05/2023</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Medical Devices</li> <li role="menuitem">Radiation-Emitting Products</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block 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