FDA Advisory No.2022-0021-A || Lifting of the FDA Advisory No. 2022-0021 entitled “Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product GRAND ADULT DIAPER”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, GRAND ADULT DIAPER, has been issued an FDA Certificate of Medical […]
FDA Advisory No.2019-333-A || Lifting of the FDA Advisory No. 2019-333 entitled “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “I-SHIELD GAUZE BANDAGE 3” X 10 YARDS”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, i-shield Gauze Bandage 3” x 10 yards has been issued an […]
FDA Advisory No.2022-1001-A || Lifting of FDA Advisory No. 2022-1001 for the Specific Product “STYLAGE IPN – LIKE TECHNOLOGY M LIDOCAINE”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, STYLAGE IPN – LIKE TECHNOLOGY M LIDOCAINE, has been issued an […]
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.2022-0605-A || Lifting the Advisory of FINECARE™ HBA1C TEST under FDA Advisory No. 2022-0605 entitled “Public Health Warning Against the Purchase and Use of Unregistered Medical Device Products”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the warning against the purchase and use of FINECARE™ HBA1C TEST as mentioned in FDA […]
FDA Advisory No.2021-2034-A || Lifting of the FDA Advisory No. 2021-2034 entitled “Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product RC SERIES RC-98 RM”
The Food and Drug Administration (FDA) informs all healthcare professionals and general public that the medical device product RC Series RC-98 RM has been notified by the Market Authorization Holder […]
FDA Advisory No.2022-0052-A || Lifting of the FDA Advisory No. 2022-0052 entitled “Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “HEALGEN® CORONAVIRUS AG RAPID TEST CASSETTE (SWAB)”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the advisory on Healgen® Coronavirus Ag Rapid Test Cassette (Swab) manufactured by Healgen Scientific Limited […]
FDA Advisory No.2021-3527-A || Lifting of the FDA Advisory No. 2021-3527 entitled Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kits: ICHROMA COVID-19 AG
The Food and Drug Administration (FDA) informs the public that Ichroma COVID-19 Ag, with Registration No. SC-2022-001, has been registered by the Market Authorization Holder (MAH), VITALINE HEALTHCARE INC., in […]
FDA Advisory No.2020-2053-A || Lifting of the FDA Advisory No. 2020-2053 Entitled “Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “KLEAN BY LUXEORGANIX FACE MASKS 3PLY EARLOOP DISPOSABLE”
The Food and Drug Administration (FDA) informs all healthcare professional and the general public that the product Klean by Luxeorganix Face Masks 3Ply Earloop Disposable, has been verified to be […]