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

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    Digi-One

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019

    SAGITT SAW-ATTACHM F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·October 6, 2014

    DEPUY ASR XL FEM IMP SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.8010379·Product code KXA·June 3, 2013

    OT PING METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 29, 2011

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·June 5, 2024

    PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 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