BEUDAMED
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    Secret Duo

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

    BIOMET CEMENTED CUP HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304450127·

    Biomet® Cemented Cup Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868343278·

    OC-Auto

    FDA UDI
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021607·Personal Use Kit OC-Auto, for Jacksonville, FL

    GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 1, 2007

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 26, 2020

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 3, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 9, 2013

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 7, 2024

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 26, 2022

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017