BEUDAMED
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    ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    E300 Dr./Asst Rear Delivery

    FDA UDI
    Engle Dental Systems, LLC·00850043433514·Wall mount 12 o'clock rear delivery dual purpose

    D-Fine™ Diamond Polishers for Hybrid Composites Trial Kit #05

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001243·Dental Burnisher

    URETHROTOME 8667.XXX AND 8670.XXX

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

    NBX - NON-BRIDGING EXTERNAL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-390)

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code LGZ·June 23, 2020

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·April 22, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

    PHILOS SR

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DXY·July 2, 2008

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 2, 2011

    Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343

    FDA Recall
    Terminated ·Product code NIK·March 10, 2005

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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