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Category: Device Advisories

FDA Advisory No.2021-2247-A || Lifting of the FDA Advisory No. 2021-2247 entitled “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “EVERX FLOW™ SHORT-FIBRE REINFORCED FLOWABLE COMPOSITE FOR DENTIN REPLACEMENT”

The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, EverX Flow™ Short-Fibre Reinforced Flowable Composite for Dentin Replacement, has been […]

FDA Advisory No.2022-1020-A || Lifting the Advisory of the Products under FDA Advisory No. 2022-1020 entitled Public Health Warning Against the Purchase and Use of the Following Unnotified Medical Device Products:

1. “PERSONA® ADULT WHEELCHAIR” 2. “PERSONA® COMMODE CHAIR (WITH PLASTIC ARM PAD” 3. “PERSONA® ADULT WALKER” 4. “PERSONA® ROUND HANDLE STICK CANE” 5. “PERSONA® SWAN HANDLE STICK CANE” 6. “PERSONA® […]

FDA Advisory No.2022-1106 || Public Health Warning Against the Purchase and Use of the Following Unnotified Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products: 1. “FIRSTAID CARING FOR LIFE 2” […]

FDA Advisory No.2022-1083 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “MEDIPACK® GAUZE PADS (4” X 4” X 12 PLY 24 X 28 MESH)”

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.2022-1082 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ALL SILICONE GASTROSTOMY BALLOON CATHETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product: ALL SILICONE GASTROSTOMY BALLOON CATHETER The […]

FDA Advisory No.2022-1078 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “AA MEDICAL+HEALTHCARE 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 product: 1. AA MEDICAL+HEALTHCARE NASAL OXYGEN CANNULA […]

FDA Advisory No.2022-1077 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “READING GLASSES”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: 1. READING GLASSES The FDA verified […]

FDA Advisory No.2022-1076 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “ORTHOFIX PLASTER OF PARIS BANDAGE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: 1. ORTHOFIX PLASTER OF PARIS BANDAGE […]

FDA Advisory No.2022-1075 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products: 1. “OLO FEELING ULTRATHIN 001 NATURAL […]

FDA Advisory No.2022-1074 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ZHONG KA 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 […]

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