BEUDAMED
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    MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014318·Zirlux 16+ D2 98.5X22

    EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLDFINGER DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEROYAL

    FDA Adverse Event
    Other ·DEROYAL INTERCONTINENTAL, S.R.L.·Product code IPY·March 15, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 8, 2011

    TENDRIL SDX

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

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·February 15, 2012

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2012

    ENTRUST AT

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·February 15, 2012

    VNGD PSRP INTLK FMRL LT 65

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·October 3, 2018

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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