BEUDAMED
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    SURGITEK URINARY DIVERSION STENT

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

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007111·AcQMap® Auxiliary Catheter Cable

    ACUMED

    FDA UDI
    Acumed LLC·10806378039966·LE Trauma System Instrument Caddy

    Falcon

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730088345·Micro Mini Pin & Ligature Cutter, 15° Angled

    ADP,1,P800,S800,1/4" N,TEKTONE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828118484·ADP,1,P800,S800,1/4" N,TEKTONE

    LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

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

    SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL MOBILE OPTIMAX220 PORTABLE X-RAY UNIT

    FDA Adverse Event
    Injury ·GE HEALTHCARE / GE MEDICAL SYSTEMS, LLC.·Product code IZL·November 23, 2021

    Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·June 26, 2024

    9MM UNILIF BONE INSERTER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code LXH·May 8, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012

    ENTERRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 11, 2010

    Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109

    FDA Recall
    Open, Classified ·Beaver Visitec International, Inc.·Product code HNN·May 10, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023