BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

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    ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551057643·Ear Loop, size 1

    Column, Ascarite, Disposable, 3.5 In

    FDA UDI
    A-M SYSTEMS, LLC·00817081026054·Column, Ascarite, Disposable, 3.5 In

    Recon

    FDA UDI
    Revelation Medical Devices·G31810152801·MIS Hip Acetabular Retractor Single Prong

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

    PHTIP DISPOSABLE ISFET CATHETER

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

    INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2020

    STINGRAY? LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 23, 2021

    FLEXTOME? CUTTING BALLOON?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·October 8, 2014

    ATTAIN

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 8, 2013

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021