BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    HITACHI Supria Whole-body X-ray CT System Phase 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111284991·TC METZ SCISS CVD DEL B/B 8"

    Custom Size B Cone Augment Reamer

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215139407·

    IPS EMPRESS DIRECT FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    TROCASYS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 8, 2023

    INTRALASE FS2 LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HNO·November 5, 2010

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 11, 2013

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·July 17, 2014

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. 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

    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