BEUDAMED
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    MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032978·Baltic Denture System BDLoad Lm6 PLSEbil2DFl C2...

    RANDOX GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIGTHSPEED 3.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013

    LOW PROFILE CROSSLINK SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015

    NC QUANTUM APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 3, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·August 25, 2014

    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·December 13, 2017

    4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024