BEUDAMED
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    YOLO CURVE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635945·CoRoent Ant TLIF PEEK, 11x10x34mm 12°

    QCT Pro Asynchronous Calibration Module, CliniQCT

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776360771·Anderson Bear Claw

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306802843·Anderson Retractor, 3 Prongs, 12cm

    OSIRIX MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 14, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 23, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 21, 2011

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·February 21, 2025

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·February 21, 2025

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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