BEUDAMED
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    Acuson SC2000 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180103016·BIPOLAR RF CABLE FOR HANDSWITCHING VALLEYLAB BI...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016193·Plate Cutter, Reconstruction, with Flange

    The Braun Corp - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588095851·The Braun Corp - 18 Metal

    V.A.C. FREEDOM™

    FDA UDI
    KCI USA, INC.·00878237000977·Vac Freedom 300ml Canister with Gel

    MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT

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

    MULTI-LINK VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT VASCULAR INTERVENTION·Product code MAF·September 14, 2005

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    1000 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·AQUATEC OPERATIONS GMBH·Product code IKX·July 1, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 3, 2014

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·September 9, 2021

    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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021