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

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    Solana GAS Assay, Solana instrument

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Oticon

    FDA UDI
    Oticon A/S·05707131282323·H16V2 TI, BTE 13 WL 85 TC

    MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXLOCK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·January 10, 2017

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    2124215-2014-16646

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVY·October 8, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 6, 2013

    LCS COMP RP INSERT STD 15MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·June 29, 2011

    MEGA 7.5FR. 40CC

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017