BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    DERMAWAVE 5000 COMBI MAX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BiomarC®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005165·Carbon Tissue Marker System, kV

    BiomarC®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005547·Fiducial Marker System, kV

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00816777026712·

    Universal

    FDA UDI
    Kalitec Direct LLC·B07301K048121·T-Handle, Torque Limiting 60In-lbs, Small Hudson

    IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

    FDA 510(k)
    FDA Class 2 ·Immunology

    STERILE BUTTON PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    ISODUR PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015

    HT70 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 3, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, CORK DIVISION·Product code JWH·May 7, 2008

    PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014