BEUDAMED
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    MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526785038·EPICOMED ELB SUPPORT SAND IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743731·ACHIMED ACHILLES SUPP SAND IV

    FINGER PULSE METER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·May 20, 2022

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    ENDEAVOR OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·March 24, 2011

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·May 9, 2008

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014