BEUDAMED
    22 results · 30ms · Sources: EU EUDAMED, US FDA

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    OR3O Dual Mobility System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 15, 2025

    Radial artery closure band

    FDA UDI
    Tianck Medical Co., Ltd.·06971162810988·

    ERGOMETER ergoselect 5 M

    FDA UDI
    ergoline GmbH·04059358001616·

    ERGOMETER ergoselect 5 P

    FDA UDI
    ergoline GmbH·04059358001623·

    CETRA

    FDA UDI
    Orthofix US LLC·18257200122394·CETRA - TOP TRAY-LEVEL, IMPLANT/INSTRUMENT CASE

    ERGOMETER ergoselect 5 T

    FDA UDI
    ergoline GmbH·04059358001630·

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180543405·Pedicle Marker, Depth Balls, Right

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402443·Reamer Guide, Tibial Cone M/L

    A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPROCESSED ENDOSCOPIC TROCARS

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

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code FEO·September 23, 2024

    SINGLE LOOP URETERAL STENT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·October 14, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013

    XTREL

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code GZF·July 19, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

    ATT MR8 FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·November 13, 2024

    ATT MR8 FOOTED

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·September 9, 2024

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022