BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    Adena-Zina System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704508932·

    Straight Cup Inserter

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215096007·

    RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS

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

    BREFORMANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    ECOLAB

    FDA Adverse Event
    ECOLAB·Product code LHC·April 6, 2016

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·April 12, 2016

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·April 8, 2016

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 8, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    COLLEAGUE PRE P1.7

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

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015