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Category: Device Advisories

FDA Advisory No.2021-0719 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Vino Apostolado (12 Medicinal Mint Herbs) 120mL”

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product: Vino Apostolado (12 Medicinal Mint Herbs) 120mL FDA Post-Marketing Surveillance (PMS) […]

FDA Advisory No.2021-0696 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product DUNHAME NASAL OXYGEN CANNULA

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products: The FDA verified through post-marketing surveillance […]

FDA Advisory No.2021-0695 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “PAEDIATRIC URINE COLLECTOR”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: The FDA verified through post-marketing surveillance […]

FDA Advisory No.2021-0694 || Public Health Warning Against the Purchase and Use of the Misbranded In Vitro Diagnostic (IVD) Medical Device “ABON® H. PYLORI ANTIBODY RAPID IN FOREIGN CHARACTERS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the misbranded in-vitro diagnostic medical device “ABON® H. PYLORI ANTIBODY IN […]

FDA Advisory No.2021-0693 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “JIADOUBAOTM DISPOSABLE MASK”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: The FDA verified through post-marketing surveillance […]

FDA Advisory No.2021-0683 || Public Health Warning Against the Purchase and Use of the following Unregistered Health-Related Device Products

The Food and Drug Administration (FDA) warns the general public NOT TO PURCHASE AND USE the unregistered health-related device products: 1. MEGAFRESH ALKALINE WATER PURIFIER (NFS 3 ALKALINE) 2. MEGAFRESH […]

FDA Advisory No.2021-0680 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product DUNHAME LUBRICATING JELLY

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: The FDA verified through post-marketing surveillance […]

FDA Advisory No.2021-0679 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “DIGITAL THERMOMETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product: The FDA verified through post-marketing surveillance […]

FDA Advisory No.2020-1778-A || Lifting the Advisory on the Registered EZ Check Infrared Forehead Thermometer under FDA Advisory No. 2020-1778 entitled Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products:

1. EZ Check Infrared Forehead Thermometer 2. Healmed Infrared Forehead Thermometer 3. Yuwell Blue Cross YT-1 Infrared Thermometer The Food and Drug Administration (FDA) informs the public that EZ Check […]

FDA Advisory No. 2021-0678 || Caution on the purchase and use of certain COVID-19 Test Kits following the performance validation conducted by the RITM

Attachments FDA ADVISORY NO. 2021-0678 (187 kB)

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