BEUDAMED
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    MICROGAS 7650 TRANSCUTANEOUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328808·TEMPLATE 3003943 ZEVO 43MM 3 LVL

    I PORT ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 26, 2024

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 2, 2019

    CEMEX SYSTEM GUN APPLICATION VERSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AMPLATZER VASCULAR PLUG 4

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code KRD·July 15, 2015

    I-PORT ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FOZ·August 9, 2024

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 9, 2019

    PDS LL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code NEW·March 14, 2013

    AIR OPTIX NIGHT & DAY AQUA

    FDA Adverse Event
    Injury ·PT CIBA VISION BATAM·Product code LPM·February 24, 2011

    HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·February 8, 2008

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 2, 2019

    UNSPECIFIED BD ECLIPSE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMF·May 2, 2019

    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

    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