BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    EPX-Series Mobile X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304007468·

    Oticon

    FDA UDI
    Oticon A/S·05707131282910·H11V2, BTE 13 WL 100 DBL

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099508·Procera Implant Bridge Ti Impl Level 9 unit

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951510380000·Femoral Downsizing Guide, Universal, 2-3 & 5-8

    ENGAGE

    FDA UDI
    Smith & Nephew, Inc.·00885556875735·FEMORAL DOWNSIZING GUIDE SZ 2-3 ...

    RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    506 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIPOLAR HEAD Ø28X55

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 14, 2018

    IDENTITY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 6, 2013

    HIP HEAD, 10/12 TAPER, 28MM, +0MM

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 30, 2011

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Biograph mMR. Model Number: 10433372.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

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