BEUDAMED
    17 results · 18ms · Sources: EU EUDAMED, US FDA

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    PIE MEDICAL SCANNER 1000

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

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700581·GC Initial™ MC Dentin DB3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700874·GC Initial™ MC Dentin DB3, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867316294·Drill Bit, AO, Ø1.7mm

    Arthrex

    FDA UDI
    Provision·B504OMAR18700580·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024551008·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024550919·

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

    PROBE, VACUUM INSULATED, SERIES 30

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TheraView TBI

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL BIT, AO, Ø1.7MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTW·June 10, 2024

    DRILL BIT, AO, Ø1.7MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTW·August 8, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 28, 2014

    ELECSYS 2010 DISK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 15, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; 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