BEUDAMED
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    OVU STICK URINE HLH KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780456704·Integra® Jarit® Obwegeser Retractor, 42mm x 10m...

    ANS1 SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIDENT T ACETABULAR SHELLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACL DISPOSABLE INST KIT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code FZX·May 30, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 2, 2016

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 11, 2015

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021