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

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    Vivid S60N, Vivid S70N

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741824500·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674182450060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1824500·18mm H x 24mm W x 50mm L x 0 degrees XLIF

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127971·2.4 X 50mm Cannulated Headed Screw, T7

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18245080·18mm H x 24mm W x 50mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L182450120·18mm H x 24mm W x 50mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X182450120·18mm H x 24mm W x 50mm L x 12 degrees XLIF

    mambo™ modular cervical plate system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536008278·mambo plate L blue, 6-hole, length 50 mm

    IDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    IONOLUX PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 7, 2013

    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, ¿ N182450-085, N182450-075, N182450-065, N182450-055, N182450-045.¿ Retractor access system that allows placement of posterior spinal fixation implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·April 10, 2013

    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, N182450-085, N182450-075, N182450-065, N182450-055, N182450-045. Retractor access system that allows placement of posterior spinal fixation implants.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HRX·February 8, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    NOVAMAX LINK GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORPORATION·Product code NBW·September 12, 2008

    OES CYSTONEPHROFIBERSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FAJ·October 29, 2022

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2014