Medical Device Fda

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

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

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

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/

2 days ago · The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' respiratory machines as most serious, saying …

Medical Device API Endpoints - Food and Drug …

https://open.fda.gov/apis/device/

Medical device names, their associated product codes, their medical specialty areas (panels) and their classification. LEARN MORE. ... A recall is an action taken to address …

Consumers (Medical Devices) | FDA

https://cacmap.fda.gov/index.php/medical-devices/resources-you-medical-devices/consumers-medical-devices

Division of Industry and Consumer Education. Center for Devices and Radiological Health. Food and Drug Administration. 10903 New Hampshire Ave. Silver …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

Medical Device Recalls. This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or …

Merit Medical Receives FDA Breakthrough Device Designation …

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

FDA Breakthrough Device Designation is intended to help patients receive timely access to technologies that have the potential to provide more effective treatment …

AccessGUDID - Identify Your Medical Device

https://accessgudid.nlm.nih.gov/

The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have …

RightEye receives FDA warning that its product is a medical device

https://www.massdevice.com/righteye-fda-warning-medical-device/

An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated Dec. …