BEUDAMED
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    HARMONE-SCHWARZER EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    X-GUIDE

    FDA UDI
    XNAV TECHNOLOGIES LLC·00817421021589·ADAPTOR SLEEVE - 11

    CosmoLock

    FDA UDI
    Kalitec Direct LLC·B073DRK0100280·Tab Breaker, Single Sided, Cosmolock MIS

    Intess C

    FDA UDI
    Kalitec Direct LLC·B07309K0100280·Caddie Lid, Cervical Implants, Hinged

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0100280·Caddie, 32-36mm Curved Cages

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0100280·Caddie, MIS Rods and Caps

    DRACO

    FDA UDI
    HNM TOTAL RECON LLC·00841742121789·DRACO MetaFuse L-Plate, Ti - (L)28mm, R

    HARDY DISK CLARITHROMYCIN, 15MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

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

    IV-SET P 180 CM PVC RLS L-L

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·February 20, 2019

    SMITH + NEPHEW

    FDA Adverse Event
    Injury ·SMITH & NEPHEW·Product code JDI·March 12, 2013

    SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRO., 8F, SL1

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 2, 2011

    RIATA ACTIVE FIXATION

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

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    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