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

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    SUREFIX INTERSPINOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MALLORY HEAD HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304225176·

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158216525·FORCEPS LANE 1X2 TEETH SERRATED STRAIGHT 5.75"

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067325·4.0mm Variable Angle, Self-Drilling Hexalobe Sc...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193112503·HA PEEK EVOS Straight, ,14mmx10mmx 22mm , BICON...

    Fuji Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711240141·Cortical-Cancellous Variable Angle Self-Drillin...

    RANDOX RX DAYTONA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STA- COAG CONTROL (N+ABN) PLUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981056568·Screw - Self-Drilling - Variable - 4.0x14mm

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052508·4.0mm x 14mm Poly Screw Assm. The Atoll OCT Spi...

    Tether™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981035945·Screw - Self-Tapping - Variable - 4.0x14mm

    VARIABLE ANGLE, HEXALOBE SCREW (TI-6AI-4V ELI)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code KWQ·June 24, 2019

    MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018

    BD US CATHENA 22GX1.00IN STRAIGHT BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·January 8, 2025

    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·May 6, 2015

    4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI)

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·June 26, 2017

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 15, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 2, 2015

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015