BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    SIERRA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iTotal® CR Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007248·iTotal® CR 12mm Tibial Keel Punch Tip Reusable ...

    K083526

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2018

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·July 20, 2021

    HARDYDISK, CEPHALOTHIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO THE GRIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    E-POLY TIBIAL BEARINGS

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

    TENDRIL STS

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 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

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 15, 2016

    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