BEUDAMED
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    DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092103135·CAMLOG® Screw-Line-compatible 4.3mm Esthetic Ab...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964023307·The ENDO CARRY-ON Procedure Kit contains all of...

    ASPIRE COVERED STENT AND DELIVERY CATHETER

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

    WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TORQUE LIMITING ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GEY·February 28, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026

    CLAV FRAC PLT,CENTRAL THIRD,RT,SS

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·January 27, 2020

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024