BEUDAMED
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    AVITA TSO/TS1 INFRARED EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002182·artVeneer life upper posteriors, L, BL3

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159018288·Vascular Clamp with 25 mm Hausmann Jaw

    BECKER MAMMARY PROSTHESIS

    FDA Adverse Event
    MENTOR CORP.·Product code FTR·May 24, 1994

    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK TOBRAMYCIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SYRINGE BOIN TUBE 10ML 21G 1-1/4IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·October 13, 2020

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·November 20, 2024

    NUTRILINE

    FDA Adverse Event
    Malfunction ·VYGON MFG·Product code LJS·September 5, 2018

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    UNKNOWN DEPUY 36X58 MARATHON LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 18, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code BRZ·August 12, 2014

    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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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