BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    MODULAR RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106110·Trial, 26 x 11mm, 8 Degree, Tapered, Straight

    R & D DESIGNATION AP-047

    FDA 510(k)
    FDA Class 2 ·Dental

    STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

    FDA 510(k)
    FDA Class 2 ·Hematology

    OG CMPLX XTRASOFT COIL 3X6

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 9, 2020

    TESS GLENOID REVERSE HEAD DIAMETER 36

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    ULTRASONIC PROBE

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code ITX·May 28, 2025

    ATLAS PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·March 14, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011

    REALIZE ADJ GASTRIC BAND STR

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL·Product code LTI·May 12, 2008

    ADVANIX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 9, 2024

    GALAXY G3 MINI 1.5MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·April 24, 2024

    ROTAPRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCX·June 18, 2024

    AXIUM PRIME BRPL 3D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code KRD·January 28, 2026

    CONCERTO NYLON

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·January 25, 2021

    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·May 4, 2016

    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code HIF·March 28, 2016