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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 …
Health Care Provider Alert: Another Counterfeit Cancer …
- https://www.fda.gov/drugs/counterfeit-medicine/health-care-provider-alert-another-counterfeit-cancer-medicine-found-united-states
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. FDA is …
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped …
King Systems Recalls King Vision Video Laryngoscope …
- https://www.fda.gov/medical-devices/medical-device-recalls/king-systems-recalls-king-vision-video-laryngoscope-adapter-size-12-due-display-reversed-image
- Device Use. The King Vision Video Laryngoscope Adapter is used to examine a patient’s upper airway and aid in the placement of a tracheal tube. The video adapter connects to …
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or …
Device Registration and Listing | FDA
- https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
- Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …
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 · Follow. Feb 16 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' (PHG.AS) …
FDA Advisory No.2023-0254 || Public Health Warning …
- https://www.fda.gov.ph/fda-advisory-no-2023-0254-public-health-warning-against-the-purchase-and-use-of-the-unregistered-medical-device-product-king-med-disposable-syringe-3-part-luer-slip-single-use-only-steri/
- The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product: 1. …
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