BEUDAMED
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    SOLARA JR. MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056615·Zirlux Multi Anterior C2,98.5X20

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011637·PedFuse Respond, CNL, 7.0mm x 70mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033387825·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0123200·Inserter, Tulips and Connectors

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS

    NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORALLITE COMPREHENSIVE EXAM TRAY

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

    CM DRIVE ACQUA IMPLANT 3.5X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

    ADVIA CENTAUR XP CKMB ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHX·March 20, 2013

    COREVALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 15, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 9, 2011

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 13, 2022

    NAVIEN INTRACRANIAL CATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·April 3, 2017

    NAVIEN INTRACRANIAL CATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·July 20, 2017

    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