BEUDAMED
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    HEARTCARD, MODEL 5258

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109450·Zirlux Multi-Unit Abutment 2 mmH compatible wit...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450306468·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361010678·PedFuse Reset, SLD, 6.0mm x 45mm

    Prima

    FDA UDI
    KEYSTONE DENTAL, INC.·D7680010945000·Ti Base Zi Abutment

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 11, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 13, 2025

    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARA 12 PLUS RETICS

    FDA 510(k)
    FDA Class 2 ·Hematology

    GIA 80-3.8 SINGLE USE LOADING UNIT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·March 7, 2013

    AKREOS ADAPT AO MICRO INCISION LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·March 4, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    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