BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    2010 PLUS HOLTER FOR WINDOWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    X-GUIDE

    FDA UDI
    XNAV TECHNOLOGIES LLC·00817421021602·ADAPTOR SLEEVE - 13

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109490·Zirlux Multi-Unit Abutment 3 mmH for CAMLOG# SC...

    PULSECO HEMODYNAMIC MONITOR CM71

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WUJIN #3 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    PLASMA Z

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL·Product code JDL·February 22, 2011

    VICTORY XL DR

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·H10·Product code KWP·April 4, 2013

    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018