BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    QT ECG (QTERD100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZESPIN SI Joint Fusion System

    FDA UDI
    Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919876281·KM33-521

    Brasseler USA

    FDA UDI
    Provision·00810041065001·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM335210·

    Clarus Digital ChannelScope Endoscope, 21.6cm

    FDA UDI
    CLARUS MEDICAL, LLC·00810004820418·Clarus Digital ChannelScope Endoscope, 21.6cm

    NA

    FDA UDI
    STERILMED, INC.·10888551007610·SAW BLADE OSCILLATING/SAGITTAL SMALL BONE

    BISBLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    AZE PHOENIX SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIGITAL CHANNELSCOPE

    FDA Adverse Event
    Malfunction ·CLARUS MEDICAL, LLC.·Product code GWG·October 31, 2025

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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