BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Blustone Synergy Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    Responsive Respiratory

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007773·Adult Oxygen Mask, Medium Concentration

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)

    CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXAN SYSTEM, MODEL NX-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IAB : 8 FR - 40 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·October 17, 2008

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013

    RESERVOIR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTN·September 5, 2023

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·March 26, 2014

    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 4, 2018

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024