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

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    Filters Regulation: Us FDA ×

    BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105315·PS2 Screw 8.5mm x 35mm

    CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    ENZYME II CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    M2A 1 PC SHELL 38MMX52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2013

    PLUM A+ DRIVER NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code MTA·May 17, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    REVITAN, RASP, DISTAL, CURVED, 14/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 11, 2018

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025