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The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...
In 2004, a pulsed electromagnetic field system was approved by the FDA as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. [6] On 8/9 September 2020 the FDA recommended to shift PEMF medical devices from the Class 3 category to a Class 2 status. [7]
Embotrap III Revascularization Device [7] Embovac Aspiration Catheter [8] Cerenovus Large Bore Catheter [9] Cerenovus Nimbus [10] Cerebase DA Guide Sheath [11] Trufill n-BCA Liquid Embolic System [12] Orthopedics (DePuy Synthes) Velys Digital Surgery platform [13] Attune Cementless Fixed Bearing Knee [14] Actis Hip Stem [15] Inhance Shoulder ...
The G5 was approved in 2016 by the FDA for use as a standalone device, while the G6 gained approval in 2018. [9] Dexcom's first G-series CGM, the G4 Platinum, received a CE mark [10] and FDA approval in 2012 [11] for adults ages 18 and over. This device improved hypoglycemic accuracy by 30%. [11]
The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. [88] [89] [90] Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML ...
FDA-approved medical devices, including oral sleep apnea devices, such as positive airway pressure machines, sleep apnea surgery, and surgically implanted devices, such as Inspire.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...