BEUDAMED
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    MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810103770·General Purpose Cleaner

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040052843·General Purpose Cleaner

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033182413·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033182420·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024021·Paddle Shaver, 7mm

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033182437·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033182376·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103070·Shaver, Closed, 7mm

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033182406·

    MASIF POWDER-FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 11, 2007

    ASPHERE M SPEC 12/14 36 +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 19, 2013

    CURLIN INFUSION 4000CMS IV PUMP

    FDA Adverse Event
    MOOG MEDICAL DEVICES GROUP·Product code FRN·February 21, 2011

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016