BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    DYMAXEON SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ HT+ 98x16 B4

    FDA UDI
    ARGEN CORPORATION, THE·D818121786·Dental porcelain/ceramic restoration kit

    ADVANIX DOUBLE PIGTAIL BILIARY STENT

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

    TITANIUM ANKLE ARTHRODESIS NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 3, 2024

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 21, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.I.·Product code NVZ·May 20, 2011

    SCEPTER XC

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code DQY·December 6, 2023

    UNKNOWN ABSORBATACK

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·August 25, 2023

    UNKNOWN PARIETEX PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·August 25, 2023

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012