BEUDAMED
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    DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878045915·NGS NARROW MUCOSA PUNCH

    103583 LuMon™ Contact Gel Kit

    FDA UDI
    SenTec AG·07640121881053·

    MOLT PERIOSTEAL ELEVATOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896053229·MOLT PERIOSTEAL ELEVATOR #CS M-9

    SUPERIOR-LOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304237193·

    LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESERVOIR 2PK 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2013

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·September 19, 2014

    SUTURE ANCHOR, BIO- PUSHLOCK, 3.5MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·May 26, 2011

    FIAB EURODEFIPADS

    FDA Adverse Event
    Malfunction ·FIAB S.P.A.·Product code LDD·October 19, 2022

    EURODEFIPADS

    FDA Adverse Event
    Malfunction ·FIAB SPA·Product code LDD·April 19, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 27, 2025

    NV EHXL ALIP LNR G4 36MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 18, 2022

    DEFICOM

    FDA Adverse Event
    Malfunction ·FIAB SPA·Product code LDD·December 21, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 9, 2026

    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code OUO·April 13, 2012

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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