BEUDAMED
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    SOLA 700,SOLA 500, SOLA 300

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

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890107241·Zirlux Implant Analog

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450135358·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0100240·Caddie, Fixed Cross Links, 5.5mm Assembly

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100240·SNII Tap, 4.50mm

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100240·Assembly, Caddie, Screws, Hinged

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100240·Caddie, Fixed Cross Links, 5.5mm, Assesmbly

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033213025·

    MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STIMULAN -CALCIUM SULFATE BONE VOID FILTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·EBI·Product code KWQ·April 14, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 19, 2013

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD. / HUNTINGTON·Product code HQL·March 2, 2011

    RIATA ST PASSIVE FIXATION LEAD

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

    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

    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