BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994582713·LOCK SCREW DRIVER 7080930 TRI-FLAT

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000884956·LOCK SCREW DRIVER 7080930 TRI-FLAT

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517320445·CoRoent® LO Ti, 9x10x30mm 5°

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16710809300·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179871·

    LIFT VB SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ATLANTIS TRANSLATIONAL SCREWS AND INSTR

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 14, 2025

    V12 COVERED STETN

    FDA Adverse Event
    Malfunction ·ATRIUM MEDICAL CORP·Product code JCT·April 24, 2013

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 8, 2011

    UNKNOWN DEPUY TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·July 22, 2008

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018