BEUDAMED
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    FOG CONTROL, LENS FOG REDUCTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANKLE TRANSFIX PIN STERILE KIT

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code KTT·February 28, 2021

    GALAXY FIXATION SYSTEM

    FDA UDI
    ORTHOFIX SRL·18033509859335·ROD D 12 MM L 300 MM

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111031·INSTRUMENT CADDY LARGE

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102367·BARRAQUER IRIS SPATULA 0.5MM

    Galaxy Fixation System

    FDA UDI
    ORTHOFIX SRL·18033509859663·ROD D 12 MM L 300 MM STERILE

    ACCOLADE-J HIP STEM SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE

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

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 4, 2014

    ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JWH·December 17, 2010

    QUICKIE IRIS 2

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LL.·Product code IOR·January 24, 2013

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code LLZ·October 14, 2013