BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    PRIMA VOLUMN VENTILATORSS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Barco

    FDA UDI
    Barco NV·05415334002999·MDSC-8255 12G NG

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124023·Modular Offset Stem 19mm x 125mm 2mm

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110959·STERILIZING CASE SMALL

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127021664·Liner Extractor Tool

    SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASAHI PTCA GUIDE WIRE FIELDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157644·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157637·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157620·

    TDX FPIA ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·December 28, 2007

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    LATEX FOLEY CATHETER, 16F

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, INC.·Product code NWR·July 15, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 7, 2011

    TDX FPIA ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·January 2, 2008

    2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·May 23, 2019

    TDX FPIA ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJQ·April 27, 2009

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 1, 2022

    LASERSCOPE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·December 30, 2011

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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