BEUDAMED
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    AUTOCUFF (PHOTOS ENCLOSED WITH 510K

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788222860·Cervical Trial 12x12x12 Convex

    MAMMOMAL INSPIRATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENCIRCLE LOCALIZATION DEVICE

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

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 20, 2014

    PLASMABLADE TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    GANDRAS

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS, INC.·Product code DQO·September 1, 2010

    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    FDA Recall
    Terminated ·Solta Medical Inc·Product code GEI·December 30, 2019

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021