BEUDAMED
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    ISOLA CLOSED DUAL ROD CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Harvest Nano Zirconia

    FDA UDI
    Harvest Dental Products, LLC·D87060038221·Harvest Nano Zirconia Color Blend A1 98.5 x 22

    LATEX AND RUBBER TOURNIQUET

    FDA Adverse Event
    Injury ·UNKNOWN·Product code GAX·October 26, 1994

    LATEX AND RUBBER BANDAGE

    FDA Adverse Event
    Injury ·UNKNOWN·Product code KGX·October 26, 1994

    AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE V-BAG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASPHERE M SPEC 11/13 36 +3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 14, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 7, 2011

    400CC EVACUATION W/ 10FR, 1/8"

    FDA Adverse Event
    Other ·MEDLINE INDUSTRIES, INC.·Product code GCY·February 26, 2008

    BD MICRO-FINE¿ PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·December 31, 2018

    SINGLE USE MECHANICAL LITHOTRIPTOR V

    FDA Adverse Event
    Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code LQC·February 15, 2024

    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