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

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    MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE

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

    iTotal® Patella Sizer

    FDA UDI
    Conformis, Inc.·00850268007156·iTotal® 35mm Patella Sizer Reusable Instrument

    Track E

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR4080530·Track E ø 3,0 x 125 mm

    Clamp, Hysterectomy, model Z 30.5cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034373125·Clamp, Hysterectomy, model Z 30.5cm

    BELLEGLASS HP ENAMEL

    FDA 510(k)
    FDA Class 2 ·Dental

    GEO STRUCTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAPERLOC MICROP FMRL 5.0MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 30, 2018

    LAMITRODE 4 LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011

    QUICKFLEX XL LV LEAD

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

    ENDOSCOPIC LINEAR CUTTER (STANDARD) - 35 MM

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

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 28, 2024

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 27, 2024

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 14, 2025

    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

    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