BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Nova

    FDA UDI
    PURELIFE, LLC·D79010601031·Nova Nitrile Powder-Free, Medium, Super-stretch...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00601031·

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04712899253158·Rachet Handle

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600130·Tray Insert 3, Cosmolock Deformity

    SURSHIELD WINGED INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVL OPTI R ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 5, 2013

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code MQP·April 15, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2008

    GORE® CARDIOFORM SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MLV·April 22, 2022

    GORE® CARDIOFORM SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MLV·April 22, 2022

    PIRANHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·March 19, 2024

    GORE® CARDIOFORM SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MLV·December 19, 2024

    GORE® CARDIOFORM SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MLV·February 11, 2022

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM

    FDA Recall
    Terminated ·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022