BEUDAMED
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    MODIFICATION TO FLOUROLAB PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810130251·Cloth Surgical Tape

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H69710130251·Cloth Surgical Tape

    Diamond D

    FDA UDI
    Keystone Industries·H66810130251·Denture Acrylic HC Light Pwd

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR60130251·Laser Facebow with stop loops without cuspid ho...

    CorticaLINK

    FDA UDI
    LINKSPINE, INC.·00817329020387·5.0mm Titanium Rod: 25mm Curved

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100250·Caddie Lid, Fixed Cross Links 5.5mm

    WAKO AUTOKIT C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELECTRICATOR MODEL 26000

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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2022

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·March 1, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·February 26, 2008

    TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

    FDA Enforcement
    Class II ·Ongoing·Innovasis, Inc·September 25, 2024

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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