BEUDAMED
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    URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VANGUARD BEARING COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    VANGUARD FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    VANGUARD TIBIAL TRAY COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·March 4, 2022

    OLYMPUS ELECTROSURGICAL UNIT

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·April 24, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 28, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016

    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