BEUDAMED
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    SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040041977·Absorbent Points Cell Pk #504

    RMO

    FDA UDI
    Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0025631·CC/ Enamel S-059

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INFINION? PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 17, 2026

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    PENUMBRA COIL 400

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·February 24, 2016

    PENUMBRA COIL 400

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·February 24, 2016

    PFC SIGMARP STB TB IN 2.5 12.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code NJL·March 13, 2013

    LOCKING SCREW, T7, 2.7X18MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·January 28, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·February 8, 2008

    ADAPTER, FOR 00241 TO PEDRIATIC SHEATHS

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HIH·February 7, 2025

    ADAPTER, FOR 00241 TO PEDRIATIC SHEATHS

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HIH·March 17, 2025

    Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 25, 2026

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·September 25, 2024

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 1, 2023