BEUDAMED
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    OEC Elite

    FDA 510(k)
    FDA Class 2 ·Radiology

    Malibu™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981028176·ANGLED HOOK, 5.5 X 6.5mm, RIGHT. The Malibu sys...

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019

    BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POWDER - FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 21, 2011

    SCRDRIVERSHAFT T25 F/URS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·June 15, 2013

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·September 18, 2008

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    FDA Adverse Event
    Injury ·TERUMO MEDICAL CORPORATION·Product code MGB·November 16, 2017

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021

    Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021