BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MDIFICATION TO MEDIPRIME

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOSCOPIC INTRODUCER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    JETSTREAM SC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 29, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 29, 2014

    BREEZE SE CEMENT

    FDA Adverse Event
    Injury ·PENTRON CLINICAL·Product code EMA·June 17, 2011

    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·November 25, 2020

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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