BEUDAMED
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    Q50 PLUS STENT GRAFT BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BullDog®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734022979·Disposable Endoscope Valves Set

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017640·Hook Punch Cut angular 3.5mm 7 degree down

    SIGMA PS CEM FEM SZ2.5 R

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·December 4, 2019

    CELL-DYN EMERALD 22 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    EXPANDABLE KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 14, 2023

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 24, 2016

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 20, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·May 26, 2011

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021