BEUDAMED
    95 results · 14ms · Sources: EU EUDAMED, US FDA

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    Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor Texas, LP, Irving, TX 75038.

    FDA Recall
    Terminated ·Mentor Texas, Inc·Product code BYY·April 21, 2008

    Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code BYY·November 7, 2003

    Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code BYY·November 7, 2003

    Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code BYY·November 7, 2003

    Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code BYY·November 7, 2003

    The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·October 2, 2013

    GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.

    FDA Recall
    Terminated ·GE Healthcare·Product code CBK·April 23, 2008

    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.

    FDA Recall
    Terminated ·Heartware, Inc.·Product code DSQ·November 19, 2018

    Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Enforcement
    Class III ·Terminated·Sterling Diagnostics, Inc.·January 4, 2017

    Brilliance iCT SP Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015

    Ingenuity CT Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015

    Brilliance 64 Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015