BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    IMPROVED DENTAL CHAIR

    FDA 510(k)
    FDA Class 1 ·Dental

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690112945·Retaining Bolt 16mm - PS/PS-C, primary tibia

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200161·Mand. 1. Molar band W-Fit left 16

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199762·Modular Tibia Tray Trial Size 6

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200160501·Mand. 1. Molar band W-Fit left 16

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200160051·Mand. 1. Molar band W-Fit left 16

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200160101·Mand. 1. Molar band W-Fit left 16

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867058118·UNIVERS TRIAL STEM, 6MM

    PIONEER STERNAL ASSIST IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Viramed Borrela All-In-One ViraChip Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2010

    NG PROMUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 17, 2013

    BIOPORE

    FDA Adverse Event
    Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 8, 2014

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017