BEUDAMED
    3,192 results · 29ms · Sources: EU EUDAMED, US FDA

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    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

    FDA Enforcement
    Class III ·Terminated·Clariance Inc·July 24, 2019

    CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CLARIANS TERUMO DIALYZER

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL CARE·Product code FJI·July 14, 1997

    CLARIANS TERUMO DIALYZER

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL CARE·Product code FJI·July 14, 1997

    CLARIANS TERUMO DIALYZER

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL CARE·Product code FJI·September 19, 1997

    CLARIANS TERUMO DIALYZER

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL CARE·Product code FJI·September 19, 1997

    NI

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 29, 2018

    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·February 6, 2013

    DRILL MICRORAPTOR HARD BONE 1.8MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MAI·December 7, 2021

    EMPOWER DUAL ENZYMATIC

    FDA Adverse Event
    Injury ·METREX·Product code LRJ·May 27, 2008

    CIOS ALPHA

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH- AT·Product code OWB·October 19, 2021

    45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

    FDA Recall
    Terminated ·Greatbatch Medical·Product code LXH·January 16, 2013