BEUDAMED
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    LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101162·DLEK CORNEAL DISSECTOR, VAULTED

    SOCRATES ROBOTIC TELEMONITORING SYSTEM

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

    XPLAN 2.2 WITH THE BODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

    M2A-MAGNUM PF CUP 60ODX54ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 12, 2013

    MLRY-HD LAT POR FMRL 15MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·November 12, 2013

    M2A-MAGNUM 52-60MM TAPER INSERT STD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 12, 2013

    RESTORATION ADM X3 INS 28/54

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·March 27, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·August 15, 2014

    CELL-DYN WBC REAGENT A

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 1, 2008

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 8, 2024

    COMP NLK SCR 3.5HEX 4.75X40 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·December 13, 2024

    COMP NLK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 8, 2024

    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