BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Collagen Meniscus Implant XL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

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

    100KGY E-POLY MAXROM ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 14, 2013

    ENDOTAK DSP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    PATELLA CLAMP

    FDA Adverse Event
    DEPUY ORTHOPEDICS INC.·Product code LXH·September 8, 2008

    COBAS 311

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 16, 2014

    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022