BEUDAMED
    262 results · 57ms · Sources: EU EUDAMED, US FDA

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    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743113000AP01615·SECURIS BLOCKER

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115240xAP04815·SECURIS STRAIGHT ROD 5.0 X 240mm

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115540xAP02115·SECURIS SCREW 5.5 x 40mm

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115160xap04815·SECURIS STRAIGHT ROD 5.0 X 160mm

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115120Xap04215·SECURIS STRAIGHT ROD 5.0 X 120mm

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115080b1ap05015e·SECURIS BENT ROD 5.0 X 80mm

    SECURIS

    FDA UDI
    CUSTOM SPINE, INC.·m743115540XAP00815·SECURIS SCREW 5.5 X 40mm

    ISSYS LP

    FDA UDI
    CUSTOM SPINE, INC.·m7430455450AP35614L·ISSYS LP Screw 5.5 X45mm

    CUSTOM SPINE, INC.

    FDA Adverse Event
    Injury ·CUSTOM SPINE, INC.·Product code LXH·February 5, 2010

    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.

    FDA Enforcement
    Class II ·Terminated·Custom Spine, Inc.·August 7, 2013

    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.

    FDA Recall
    Terminated ·Custom Spine, Inc.·Product code NKB·March 28, 2013

    ISSYS PEDICLE SCRE SYSTEM

    FDA Adverse Event
    Other ·CUSTOM SPINE, INC.·Product code KWP·April 3, 2012

    ISSYS PEDICLE SCREW 6.5 MM X 50 MM

    FDA Adverse Event
    Malfunction ·CUSTOM SPINE, INC.·Product code MCV·November 26, 2008

    06.5MM ISSYS PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·CUSTOM SPINE, INC.·Product code MCV·June 22, 2006

    ISSYS PEDICLE SCREW

    FDA Adverse Event
    Other ·CUSTOM SPINE, INC.·Product code MCV·February 25, 2008

    ISSYS LP SPINAL SCREW

    FDA Adverse Event
    Malfunction ·CUSTOM SPINE, INC.·Product code NKB·July 2, 2010

    OPTRELL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·August 13, 2025

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code MTD·February 25, 2019

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·June 8, 2024

    PENTARAY NAV

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·September 23, 2024