BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    iHealth View BP7S Wireless Blood Pressure Wrist Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Liner Inserter

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076290·

    LTF-Y0009; MAJ-YOO41; XOEV-3D1

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

    MIM 3.5 (CIRCA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 3, 2014

    CAPSUREFIXNOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    NEXGEN RHK ARTICULAR SURFACE PROVISIONAL

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·June 28, 2011

    CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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