BEUDAMED
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    ACISTCVi® Contrast Delivery System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Novo Surgical Inc

    FDA UDI
    NOVO SURGICAL, INC.·00842331192715·tissue forceps, standard pattern, serrated hand...

    NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120

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

    BD PHASEAL¿ INFUSION SET (C50)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code LHI·June 28, 2019

    CORTISOL

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NHG·July 19, 2013

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 14, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 21, 2011

    PFNA BLADE L90 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HSB·June 15, 2013

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·December 31, 2024

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    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