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    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT

    FDA Enforcement
    Class II ·Ongoing·Sophysa S.A.·May 22, 2024

    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT

    FDA Enforcement
    Class II ·Ongoing·Sophysa S.A.·May 22, 2024

    TD-Synergy. Laboratory Information System.

    FDA Enforcement
    Class II ·Terminated·Technidata S.A.·May 29, 2013

    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.

    FDA Enforcement
    Class II ·Terminated·MEDICAMAT S.A.·March 12, 2014

    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    FDA Enforcement
    Class II ·Terminated·Kiscomedica S.A.·March 22, 2017

    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

    FDA Enforcement
    Class II ·Ongoing·Technidata S.A.·May 17, 2023