BEUDAMED
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    BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

    Depth gauge

    FDA UDI
    Jeil Medical Corporation·08800089430956·

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657047135·Allis, 5mm, Fine Axial Serrations Handle: 1366...

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089466313·

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657044219·Hook Scissors, 5mm Version Handle: 1366 Standa...

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964100093·Endo Carry-On Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964100604·Endo Carry-On Procedure Kit

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·August 17, 2020

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·July 8, 2020

    I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)

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

    CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·June 22, 2020

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·May 9, 2013

    UNKNOWN DEPUY ACETABULAR SCREW

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HWC·September 23, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·May 18, 2011

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·September 2, 2020

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·July 9, 2022

    Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019