BEUDAMED
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    INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Zimmer, Inc.·00889024156067·

    NA

    FDA UDI
    Zimmer, Inc.·00889024156074·

    ZIMMER

    FDA Adverse Event
    Injury ·ZIMMER·Product code KWB·December 20, 1996

    Disposable Medical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET

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

    TOTAL HIP PROSTHESIS

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·January 4, 1996

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 9, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·November 18, 2010

    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.

    FDA Recall
    Terminated ·Sekisui Diagnostics Llc·Product code LDP·May 29, 2012

    DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009

    DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009

    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code CHH·November 10, 2010

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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