BEUDAMED
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    DISPOSABLE SURGICAL DRAPES AND ACCESSORIES

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

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668615311·Senseus Flexofile Size 015 31mm

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809640298·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...

    SPACE CPSXL BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENRHYTHM MRI

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 2012

    INSYNC

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·October 8, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012