Fda News Medical Devices

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Medical Devices News and Events | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes January 10, 2023 CDRH Statements - Statements from the Center for Devices and Radiological Health …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Medical Devices | FDAnews

https://www.fdanews.com/topics/106-medical-devices

The FDA has issued a warning letter to Nendingen, Germany-based laparoscopy devicemaker Getsch+Hiller Medizintechnik (GH) for unapproved product changes, the lack of a design history file …

U.S. FDA classifies recall of Philips' respiratory devices as most ...

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-recall-philips-respiratory-devices-most-serious-2023-02-16/

1 day ago · Feb 16 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' (PHG.AS) respiratory …

CDRHNew - News and Updates | FDA

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

Federal Register: Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal …

2023 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls

2023 Medical Device Recalls | FDA An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu …

Recently-Approved Devices | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices

Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the …

Identifying Products as Medical Devices: The FDA’s Rules

https://www.fdanews.com/articles/211071-identifying-products-as-medical-devices-the-fdas-rules

Identifying Products as Medical Devices: The FDA’s Rules | FDAnews Identifying Products as Medical Devices: The FDA’s Rules February 7, 2023 Medical …

Augmented Reality and Virtual Reality in Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices

List of Medical Devices that Incorporate Augmented Reality and Virtual Reality The FDA has reviewed and authorized for marketing a growing number of …

Merit Medical Receives FDA Breakthrough Device Designation …

https://finance.yahoo.com/news/merit-medical-receives-fda-breakthrough-142500617.html

SOUTH JORDAN, Utah, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of …

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