BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HUMERAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868004896·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528103135·7.0 x 115mm Cann Hdless Screw, 32mm Thd

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528107492·7.0 x 115mm Hdls Screw 32Thd Sterile 2Pk

    COMFORT TOUCH INSUIN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021

    PERIPHERAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PK SUPERPULSE SYSEM GENERATOR MODEL 744000

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    COTTON-HUIBREGTSE BILIARY STENT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FGE·July 14, 2022

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 23, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·June 22, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 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

    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