BEUDAMED
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    SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00533151·

    CAMLOG

    FDA UDI
    Preat Corporation·00842092167335·CAMLOG® Screw-Line-compatible 3.8mm Non-Engagin...

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033150·RESP-Film Cassette Insert

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180165601·MALIS TYPE BIPOLAR FORCEPS BAYONET 1.5MM

    LAMITRODE 4 LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2017

    LAMITRODE 4 LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2017

    MODIFICATION TO KION ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VENTRICULAR ANALYSIS TOOLKIT OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUATTRODE LEAD WIDE SPACED, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·June 20, 2017

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 21, 2014

    SECURE FLOW

    FDA Adverse Event
    Injury ·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWE·May 25, 2021

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTERNATIONAL·Product code KWA·March 14, 2013

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·February 28, 2011

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·February 27, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024