BEUDAMED
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    T3 Platform Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514926·

    OC-Auto

    FDA UDI
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021416·Personal Use Kit OC-Auto, for West LA, CA

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·June 4, 2004

    MOSAIQ ONCOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERCON BASE

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 14, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 13, 2023

    ENSITE CLASSIC SYSTEM

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

    TOTALCARE BED

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

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    INFORMATION CENTER NETWORK DATABASE

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 1, 2013

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023