BEUDAMED
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    K2 BONE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295233190·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING TC3 3 ...

    EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Navio

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stealthstation® S7¿

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 28, 2019

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·November 13, 2019

    STEALTHSTATION S8 PREMIUM SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·September 3, 2019

    STEALTHSTATION S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 3, 2021

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 21, 2019

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·November 27, 2019

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·February 12, 2013

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·January 13, 2011

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 21, 2014

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 3, 30.0 mm; Ref 96-0537.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·November 21, 2022