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

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    5F GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964004887·CUSTOM PROCEDURE KIT

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048311632·FRAME FIXATION STERILIZING TRAY

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741121128·Catheter Placement Kit

    GC Reline ™

    FDA UDI
    Gc America Inc.·D0470005981·GC Reline ™ Soft Intro Package 1 (48mL) cartrid...

    ESU Shroud

    FDA UDI
    I.C. MEDICAL, INC.·00817688022640·ESU Shroud, Short Tip, 1’ Tube, Sterile

    TEMPUS LS - MANUAL

    FDA Adverse Event
    Malfunction ·SCHILLER AG·Product code LDD·October 30, 2025

    CORTEK ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOFTLINE SPRING CLIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    CONCERTO

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·April 8, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE·Product code ITI·February 2, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 21, 2008

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017