BEUDAMED
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    Venturi Gauze Wound Care Sets with Portal Drain

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Oticon

    FDA UDI
    Oticon A/S·05707131288653·RIA2 PRO, DESIGNRITE 10 WL MIBU

    Prolift Post-Pack Instruments

    FDA UDI
    Life Spine, Inc.·00190837031831·

    CUSA EXCEL 36KHZ TUBING SET

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·December 9, 2015

    EVITAXL WITH OPTION SMARTCARE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    COULTER AC*T DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 7, 2013

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·June 30, 2011

    MICROLAB AT PLUS 2

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·July 1, 2008

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018