BEUDAMED
    28 results · 23ms · Sources: EU EUDAMED, US FDA

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    KEYSTONE HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005211·SC 8 oz Liquid

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00505211·

    intellijoint KNEE®

    FDA UDI
    Intellijoint Surgical Inc·00628184005217·Bone Tracker

    GeneXpert Dx System

    FDA UDI
    CEPHEID·07332940001483·Additional catalog numbers: 900-0521-14, 900-0521R

    AESCULAP BONE WAX

    FDA 510(k)
    FDA Unclassified ·Unknown

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

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 5, 2019

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KXA·December 5, 2019

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 5, 2019

    BONE WAX 24X2.5G

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MTJ·October 30, 2019

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 12, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 1, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·February 15, 2008

    BONE WAX 24X2.5G

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MTJ·May 7, 2019

    WALLACH ULTRA FREEZE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·September 8, 2022

    MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013