BEUDAMED
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    VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Symmetry Malis®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482140017·Forcep Bipolar Bayonet Straight Titanium 0.5mm ...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180506691·Longer Rotating Distractor, Holed, 7mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm

    BD INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·January 13, 2025

    R STENT BILIARY ENDOPROSTHESIS

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

    SMARTEPIL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·May 6, 2005

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·May 6, 2005

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·November 22, 2012

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011

    3.5MM CORT LOCK SCRW 26MM

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'R.L.·Product code HRS·July 18, 2008

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014