BEUDAMED
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    KSEA MINIATURE TELESCOPE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109870·Zirlux Titanium Esthetic Abutment Anterior comp...

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517063434·MaXcess Access Tip, Light Cable

    EXPLORER GRADIENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    VFSS IMAGER, MODEL SIS-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    9900

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

    DIMENSION(R) CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JGS·March 8, 2011

    IDENTITY DR

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

    Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number: 010987-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·December 1, 2011

    Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012

    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