BEUDAMED
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    FISCHER WIRE/PIN CLAMP

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482097·SCREW 6860018 VA SELF TAPPING 4.0X18MM

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989051599·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 18

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600181·Max. 2. Molar band W-Fit left 18

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707032007·WEB 1ST MOLAR BANDS n.LR 18

    Sternum Retractor

    FDA UDI
    KOROS U.S.A., INC.·10840199536129·Sternum Spreader Pediatric Size 5, 4-1/4" Arm L...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180167391·Sternal Spreaders with Double Blades, Arm Lengt...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600180101·Max. 2. Molar band W-Fit left 18

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600180051·Max. 2. Molar band W-Fit left 18

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600180501·Max. 2. Molar band W-Fit left 18

    TRULENE MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Arrow Quickflash Arterial Catheterization Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTA SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MED DEVICES GROUP·Product code FRN·October 31, 2012

    STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·September 17, 2010

    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016

    IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 18, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024