BEUDAMED
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    Standard Catheter Set

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584070116·SA5 IICX, WL BL SAPHIRA 5

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331132056·tissue forceps, standard pattern, serrated hand...

    NICOM ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KNW·March 12, 2026

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·October 14, 2014

    SAW BLAD 37/22*8*0.4/0.3

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

    PRECISION XTRA

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

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 8, 2025

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 9, 2025

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code LWE·October 8, 2025

    BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code MEG·February 24, 2020

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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