BEUDAMED
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    NEURO CHECK DEVICE WITH IO-FLEX WIRE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074250816·CROSSLINK 8113533 X10 FOR 3.5ROD L 33

    Oticon

    FDA UDI
    Oticon A/S·05707131234476·K50, ITC/ITE T BE KIT

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003334·65 V2 EX SMALL 22ID ELB W/HG

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045319·Curved Sizer, 10mm

    EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    UNKNOWN DEPUY DEVICE

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·May 15, 2013

    ENDURANCE BONE CEMENT 40G

    FDA Adverse Event
    Injury ·DEPUY CMW 9610921·Product code LOD·September 24, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 3, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code ELC·April 29, 2020

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·May 31, 2023

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025