BEUDAMED
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    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002104·artVeneer life upper posteriors, M, C2

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00121041·

    Astra

    FDA UDI
    Preat Corporation·00842092129494·Astra®-compatible Aqua 3.8 X 9.0mm Closed-Tray ...

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159029512·Dennis Anastomosis Clamp

    BetaForce™

    FDA UDI
    Ortho Organizers, Inc.·00190707124359·BETAFORCE Beta³ Upper .018 (10pk)

    BetaForce

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730021946·Beta3 Upper 018 10 archwires per pack

    BOTANIQ

    FDA UDI
    Inspecs U.S.A., L.C.·00841543148381·SUNGLASS

    BD PHASEAL OPTIMA INFUSION ADAPTER (C100-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·December 22, 2020

    XIMX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZYBIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSION ADAPTER C100

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 26, 2020

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 14, 2011

    PHILOS II DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code DXY·March 13, 2013

    GATEWAY BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·February 28, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008

    INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MAF·February 16, 2022

    Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code GCY·July 11, 2003

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012