BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    Glocyte Automated Cell Counter System

    FDA 510(k)
    FDA Class 2 ·Hematology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284935·GELPI RETRACTOR 3 1/2" SHARP POINTS

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704921055·

    Lightning Curved Reamer Handle

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215074814·

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 3, 2021

    EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 5, 2018

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code LWP·June 8, 2013

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    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