BEUDAMED
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    4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037305638·RING CUTTING GUIDE Ø43 mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155424·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links

    PC

    FDA UDI
    Allied Medical, LLC·00026072012437·COUPLER CMPD SAFETY KEYED

    uNion MAX

    FDA UDI
    Ulrich Medical Usa, Inc.·00810076334592·High Angulation Plate, 2-Level, 43 mm

    BD SYRINGE 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·January 28, 2026

    DRG AURICA ELISA TESTOSTERONE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PELVEX HOMETRAINER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 25, 2013

    AGILITY TALAR SZ 5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSN·March 11, 2011

    ENCODER, J6, HIP 190-00137

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·September 19, 2018

    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

    FDA Recall
    Terminated ·Insightra Medical Inc·Product code DSP·July 19, 2025