BEUDAMED
    25 results · 111ms · Sources: EU EUDAMED, US FDA

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    Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517197184·MaXcess 4 Blade, 100mm Left

    CANNULATED TAP 7.0mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665001075·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022644·FPS 2.7mm 4 Hole Straight Compression Plate

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690123668·Femoral Posterior Augment Trial, Size 1+, 10mm

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690121282·Femoral Augment Posterior, Size 1+, 10mm

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522411000·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694076869·FPS 2.7 4 Hole Straight Compression Plate Steri...

    OPTILITE C1 INACTIVATOR KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

    FDA Adverse Event
    Injury ·SYNTHES HAGENDORF·Product code FZX·August 25, 2015

    HATCP STEM POR TIB PLT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 5, 2024

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 21, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·July 18, 2013

    BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024