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

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    PREMIER CARVERS, STYLE #21C & 21D

    FDA 510(k)
    FDA Class 1 ·Dental

    E-POLY TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InstruSafe(R) Sterilization Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 10, 2012

    NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code MBH·May 18, 2015

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025