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    REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 30, 2025

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543405·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543399·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543382·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543436·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543375·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543429·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033543412·

    SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2019

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·March 20, 2013

    UNIVERSAL I ACETABULAR CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 10, 2011

    DISPOSABLE VARICES INJECTOR (DEVICE 1 OF 2)

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code GAA·March 12, 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