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

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    GOLDEN MEAN MACHINE(TM) (CLASS 2)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377035493·RELINE-C Bender Tip, Ø4.0 Ang Sag Left

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077960·CURVED CHISEL

    ORTHOSS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAMBA and MAMBA Flex Microcatheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GIALLOY CB-H

    FDA UDI
    SRL Dental GmbH·ESRL58904011·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...

    PYRAMESH® IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 3, 2010

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    ANI [ A&I ] GROUP TAIWAN·Product code IOR·December 29, 2012

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    PYRAMESH IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020