BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    ENCORE HUMERAL SHOULDER STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP

    FDA 510(k)
    FDA Class 2 ·Radiology

    ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11

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

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code KWP·May 19, 1999

    INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·May 9, 1997

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    1.65X5MM HT SD X-DR SCREW 50PK

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code JEY·March 7, 2023

    ADVIA CENTAUR XPT

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016

    fastener, fixation, nondegradable, soft tissue

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    GAMMA CAMERA

    FDA Adverse Event
    Malfunction ·TOSHIBA MEDICAL SYSTEMS OF AMERICA·Product code IYX·April 17, 1992

    AIMING ARM FOR SUPRAPATELLAR

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·February 22, 2017

    INSERTION HANDLE FOR SUPRAPATELLAR

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·February 22, 2017

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HTW·February 22, 2017

    8.0MM/3.2MM DRILL SLEEVE 200MM

    FDA Adverse Event
    Injury ·SYNTHES HAGENDORF·Product code LXH·February 22, 2017

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·October 17, 2013

    AIMING ARM FOR SUPRAPATELLAR

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code JDS·October 20, 2015