BEUDAMED
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    Humerus & Ulna System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM

    STILLE Osteotomes

    FDA UDI
    Stille AB·07332339206413·OSTEOTOME ORIGINAL STILLE 8 mm 16.5 cm 6.5 in

    Vu a-POD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981038137·31x24mm Trial 8mm 12 deg. The Vu a-POD interve...

    BIOSUC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TVC IMAGING SYSTEM MODEL NIRS-MC7-70

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    SHOULDER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·December 2, 2024

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 23, 2008

    LINOX SD 65/18

    FDA Adverse Event
    Death ·BIOTRONIK SE & CO. KG·Product code LWS·August 9, 2011

    ENDOTAK DSP

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·July 9, 2013

    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs

    FDA Enforcement
    Class II ·Terminated·Nuvectra·May 11, 2016

    DRX Revolution Mobile X-Ray System

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