BEUDAMED
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    DISTAL RADIO-ULNAR JOINT IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531191·

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005373·SST TAP, 2.0mm Dia., 1.5mm DRILL, 2.0mm SCREW

    VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    PROXIMATE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GCJ·May 20, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    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