BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006465·HEAD SUPPORT W/O CB 2630/2730

    ATAC PAK CPK REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLAATZ 750E

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 24, 2023

    STEM: AMISTEM H HA COATED STD STEM SIZE 5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 5, 2023

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 14, 2013

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·March 10, 2011

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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