BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    E-POLY TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    E-POLY TIBIAL BEARINGS

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

    iTotal® Patella Sizer

    FDA UDI
    Conformis, Inc.·00850268007132·iTotal® 29mm Patella Sizer Reusable Instrument

    ADARA

    FDA UDI
    HNM TOTAL RECON LLC·00841742102740·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...

    TITANIUM CEMENT RESTRICTOR MATERIAL PEEK

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

    ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

    FDA 510(k)
    FDA Class 1 ·Hematology

    COBAS E 411 ANALYZER (DISK SYSTEM)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 10, 2025

    VERCISE GENUS¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 1, 2022

    TENDRIL STS

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

    6F ANGIO-SEAL EVOLUTION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·April 22, 2011

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING

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

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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