BEUDAMED
    1,161 results · 40ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    AIRVIEW MINI OWIE DICK TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·May 13, 2020

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·May 13, 2020

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·April 19, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·November 8, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·November 8, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·December 6, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·December 6, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·December 6, 2019

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·November 8, 2019

    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·March 7, 2018

    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code GCP·August 18, 2017

    NILE ALTERNATIVE FIXATION SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code OWI·November 18, 2016

    JAZZ LOCK

    FDA Adverse Event
    Injury ·IMPLANET·Product code OWI·November 24, 2017

    UNIVERSAL CLAMP GENERIC

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code OWI·October 31, 2014

    ARTHRO BIOINDCTIVE IMPLANT 1 LARGE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code OWY·April 23, 2021

    UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code OWY·June 16, 2021

    TRANSLACE SPINAL TETHERING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code OWI·May 5, 2021

    BIOINDUCTIVE IMPLANT W/ARTH DEL LRG

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code OWY·May 13, 2021

    BIOINDUCTIVE IMPLANT W ARTHRO DEL MED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code OWY·May 14, 2021