BEUDAMED
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    3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040035917·Channels Endo Piezo Tip 5 CPTE5

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717103582·Midway Select Burs FG 37 Pkg/10

    ES™ TROCHANTERIC NAIL, LEFT, Ø10mm x 36cm x 125°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022018·

    DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ADVANTAGE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·March 10, 2023

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 26, 2013

    VISCOAT

    FDA Adverse Event
    Injury ·ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.·Product code LZP·March 11, 2011

    PULSE GEN

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·March 25, 2008

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 30, 2023

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 5, 2023

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024