BEUDAMED
    24 results · 23ms · 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 ×

    SOLO-L

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zavation

    FDA UDI
    Zavation LLC·00842166132863·Ti3Z CIF 14mmx16mmx10mm -6 deg

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113355·PS Insert, Size 6 x 10mm

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220610150·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220610070·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676220610000·

    LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Customized Contour Implant

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

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC.·Product code KWY·September 21, 2006

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC.,·Product code KWY·July 12, 2007

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC.·Product code KWY·April 21, 2009

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNILIFE SCIENCE INC.·Product code KWY·June 25, 2007

    BD NEEDLE 30GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·May 7, 2024

    VADER pedicle system, torque wrench, Catalog Number 42-702

    FDA Enforcement
    Class II ·Ongoing·Icotec Ag·January 17, 2024

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·November 3, 2014

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·June 24, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 15, 2011

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 28, 2023

    BD NEEDLE 30GA 1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 28, 2023

    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

    FDA Enforcement
    Class II ·Terminated·Immuno-Mycologics, Inc·June 17, 2020