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

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    MODIFICATION TO TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013434·Zirlux 16+ B1 98.5X14

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01106T0·Cervical Trial, 14 x 11, 6mm, 7 Degree, Tapered

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01106N0·Cervical Trial, 14 x 11, 6mm, 0 Degree, No Taper

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 19, 2025

    DADE BEHRING COAGULATION ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 28, 2025

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

    3DKNEE

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code JWH·March 19, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 8, 2011

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

    FDA Adverse Event
    Death ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 2018

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021