BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Mobility Scooter (W3331)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994318862·BASE 6240008 BASE ANATOMIC

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517195623·MaXcess 4 Set Screw, Short

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982164247·4.5MM PROXIMAL TIBIA PLATE 8 HOLES/RIGHT

    VP1200K™

    FDA UDI
    VASCUTEK LTD·05037881020013·VP1200K Knitted Vascular Prosthesis STRAIGHT

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075029544·SPLIT STOPS W/ BALL HOOK STRAIGHT PK10

    INSERT CENTERING SLEEVE

    FDA UDI
    Osteocentric Technologies, Inc.·00810189110366·INSERT CENTERING SLEEVE

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·saypha® MagIQ™

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016074·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012441·

    DYNAFORCE

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code JDR·September 29, 2022

    VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM

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

    QUICKVUE ADVANCE PH AND AMINES GLL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSSCLIP

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS·Product code JDR·September 29, 2022

    ATRICURE WOLF LUMITIP DISSECTOR

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code FTD·January 17, 2007

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 8, 2011

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013