BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Patient Contoured Implant-PEEK (PCI-PEEK)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELECSYS PROBNP IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 12 HOLES, 278 MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·November 23, 2017

    PENUMBRA SYSTEM 5MAXACE REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 5, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·November 29, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2015

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology