BEUDAMED
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    OPDIMA

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328792·TEMPLATE 3003945 ZEVO 45MM 3 LVL

    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARA 12 PLUS RETICS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SECURE FLOW

    FDA Adverse Event
    Injury ·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 14, 2013

    TRILOGY ACE SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER RANDALL ASSOC·Product code KWZ·February 23, 2011

    2250051-2008-00064

    FDA Adverse Event
    Malfunction ·Product code JTC·February 1, 2008

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022

    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