BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    iTotal® CR Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007231·iTotal® CR 10mm Tibial Keel Punch Tip Reusable ...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197541367·RZ Tebbet Breast Retractor 80x25m...

    ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARDYDISK OFLOXACIN 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    ZEPHYR XL SR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·April 26, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·April 22, 2011

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 24, 2008

    CORIN METAFIX HIP STEM

    FDA Adverse Event
    Injury ·CORIN MEDICAL·Product code LZO·September 6, 2022

    UNKNOWN BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024