BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799004321·

    SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295242482·SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE ...

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111392601·PROBE W/EYE 5.5 INCHES STERL CS/25

    INNOVACON HCG UKTRA TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Soft Plug Extended Duration 180 Canalicular Plug

    FDA 510(k)
    FDA Unclassified ·Unknown

    CONSULT HCG TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    LEGEND TAPERED DISSECTING TOOL

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·February 14, 2013

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 7, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2014

    CONSULT HCG URINE CASSETTE 5001 25T

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HXB·December 3, 2024

    1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

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