BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    AKCESS-CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VACUUM-ASSISTED BLOOD COLLECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHARPS CONTAINER

    FDA Adverse Event
    Malfunction ·POST MEDICAL, INC.·Product code FMI·March 12, 2024

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 22, 2013

    NDEHP LS SEC 34'OL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPK·November 8, 2010

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 18, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024