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

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    SIGMA STERILIZATION POUCH & ROLL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021580·SPIRA®-A Integrated,Trial, 32x38mm, 25° Lordoti...

    Tibial Trial Tray 3

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056551·

    S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: LONG LENGTH GAMMA NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 16, 2022

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 17, 2014

    ENTRAK 2500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·May 19, 2011

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Death ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 16, 2026

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 17, 2026

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 22, 2016

    ACTIVA

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code MHY·September 22, 2016

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021