BEUDAMED
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    CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040128701·Elevator Goldman Fox #14

    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

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

    WILSON-COOK REUSABLE HOT BIOPSY FORCEPS

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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 10, 2022

    V500, SAVINA AND VENTILATORS OF EVITA FAMILY

    FDA Adverse Event
    Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

    2520274-2013-01430

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MNI·March 13, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 8, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024