BEUDAMED
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    geko T-3 Neuromuscular Stimulator

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515067493·Green Ret, 8 1/2"

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515024724·Green Ret, 8 1/2"

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970379·

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

    FDA 510(k)
    FDA Unclassified ·Unknown

    AEQUALIS REVERSED SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 20, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·July 7, 2011

    RIGHT ANGLE LINEAR CUTTER, 30MM DLU

    FDA Adverse Event
    Malfunction ·POWER MEDICAL INTERVENTIONS·Product code GDW·September 29, 2008

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·January 20, 2022

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021