BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    MicroLink All-Suture Button Fixation System (Radiolucent)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197187817·Distraction Screws 16 mm

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402269·Guide Rod, Tibial Cone, D 16/120 L

    CONNEX VITAL SIGNS MONITOR 6000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANYPLUS PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TARGETING ARM T2 PROX. HUM.

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA GMBH·Product code LXH·August 7, 2012

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 28, 2024

    NAV THORACIC PROBE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·November 25, 2019

    NAV THORACIC PROBE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·November 25, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 4, 2011

    CONTINUOUS NERVE BLOCK KIT

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code CAZ·June 21, 2013

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code LJS·November 6, 2019

    SKINTACT

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·December 11, 2019

    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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022