BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    MP-3 POWER BASE CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982066·posteriors; shade B4; size L; upper jaw

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111380648·GOMEL MICRO SCISSORS CVD 6.25"

    TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

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

    ACCU-CHEK INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code FPA·February 8, 2013

    ACCU-CHECK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·January 14, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·August 5, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021