BEUDAMED
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    TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292732·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049071·K-Wires, Single trocar, .028-inch (.7mm) diamet...

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012498·K-Wires, Single trocar, .028-inch (.7mm) diamet...

    Prosthesis Head Large

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575993321·Prosthesis Head,

    DRIDAU OPIATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 10, 2025

    CLIK X MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2021

    ACCU-CHEK ® FASTCLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 27, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025

    Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

    FDA Enforcement
    Class I ·Terminated·Abbott Diabetes Care, Inc.·May 15, 2013

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022