BEUDAMED
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    GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441299·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441282·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441329·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441312·

    BIOCELLECT

    FDA 510(k)
    FDA Class 2 ·Dental

    DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BILATERAL DOUBLE BALLOON SET

    FDA Adverse Event
    Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 4, 2023

    ULTRAFLEX¿ ESOPHAGEAL NG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code ESW·March 20, 2013

    ELECTRIC MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 3, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·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

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024