BEUDAMED
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    Reprocessed IntellaMap Orion High Resolution Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VENOTRAIN CURAFLOW

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 29, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    M2A MAGNUM 42-50M TAPER INSERT +6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 8, 2013

    BD BBL¿ MACCONKEY AGAR

    FDA Adverse Event
    Malfunction ·BD CUAUTITLAN·Product code JSI·January 6, 2026

    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·December 6, 2011

    StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020