BEUDAMED
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    DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036284374·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036174101·

    BEHRING COAGULATION SYSTEM (BCS)

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPLINE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    9900

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

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 8, 2011

    QUICKSITE LV

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

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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