BEUDAMED
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    MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

    ADVIA CENTAUR HOMOCYSTEINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GUARDED NEEDLE 2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDACTA KNEE IMPLANTS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    BQ-SYTE CLOSED LUER ACCESS DEVICED

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·March 7, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·January 2, 2025

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·April 25, 2024

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·May 7, 2024

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 11, 2024

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·April 4, 2024

    BD Q-SYTE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 18, 2024

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·September 16, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 4, 2011

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR35

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011