BEUDAMED
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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.

    FDA Enforcement
    Class III ·Terminated·Trumpf Medical Systems·November 13, 2013

    inLight Medical LED Pads used with Polychromatic light technology system

    FDA Enforcement
    Class III ·Terminated·Inlightened Partners LLC·June 30, 2021

    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    FDA Enforcement
    Class III ·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013

    D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    FDA Enforcement
    Class III ·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013

    Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN

    FDA Enforcement
    Class III ·Ongoing·Abbott Medical·December 4, 2024

    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.

    FDA Enforcement
    Class III ·Ongoing·Abbott Medical·December 4, 2024