BEUDAMED
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    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152030·Endo Carry-on Procedure Kit contains Basin, VIA...

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 15, 2025

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

    RHIGENE MESACUP2 TEST- SM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

    X-STOP® INTERSPINOUS SPACER

    FDA Adverse Event
    Injury ·MDT KYPHON SUNNYVALE MFG·Product code NQO·March 19, 2013

    HAKIM IN LINE PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·March 2, 2011

    RIATA ST OPTIM ACTIVE FIXATION

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

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·May 1, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·April 28, 2014

    COULTER ISOTON III DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GIF·March 27, 2014

    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

    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