BEUDAMED
    24 results · 20ms · Sources: EU EUDAMED, US FDA

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    WIREGUIDE OR GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DD cubeY® HL

    FDA UDI
    Dental Direkt GmbH·EDDIG8430121·The DD cubeY® HL zirconium dioxide milling blan...

    Buxton Biomedical

    FDA UDI
    Buxton Biomedical Inc·B7688430120·Sm-Hndl Punch, 180x1mm,40°up

    OMNIPULSE MINI, MODEL 2120

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MIM – Symphony HDR Fusion

    FDA 510(k)
    FDA Class 2 ·Radiology

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136496·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136526·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136502·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136465·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136519·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136472·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024136489·

    NA

    FDA UDI
    Zimmer, Inc.·00889024195066·

    NA

    FDA UDI
    Zimmer, Inc.·00889024195073·

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2014

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIM·November 21, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·September 23, 2010

    VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016