BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    WILSON-COOK BILIARY MOTILITY CATHETER

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

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053020599·Barricade Coil System (BCS) is intended for the...

    SAFIRA

    FDA UDI
    MEDOVATE LIMITED·05060727270051·Sterile SAFIRA 20 mL syringe (NRFit)

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828186704·GEN4 INTERACTIVE GEN4 INTERACTIVE

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099373·DB BRACKET MASTER SERIES MAND RIGHT 2ND BICUSPI...

    CONLIN MOLAR BANDS

    FDA UDI
    Ortho Arch Company Inc·D90990005819·MOLAR BAND CONLIN RX LOWER LEFT 42 1/2

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508107170·Off Center Torque Handle

    XBraid TT

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00810020084962·Suture Tape

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·FLEXLENS (HEFILCON A) SOFT CONTACT LENSES

    YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ALEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·May 27, 2014

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 8, 2010

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·December 26, 2012

    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019

    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 7, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012