BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Thermidas IR System (ThIR-A615)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    HHM

    FDA UDI
    Oticon A/S·05707131349996·G500 S, BTE PP 13 2.4G 105 C092 HHM

    MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM --

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 7, 2016

    C6 WITH UNIVERSAL ELECTRODE PATCH

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·November 4, 2022

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 27, 2014

    ADJ PIN COLLET 2.0 - 3.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·July 1, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

    20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016