BEUDAMED
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    XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131165312·K140, ITC/ITE AP WL L BE

    Tasso+

    FDA UDI
    Tasso Inc.·00860006434595·

    Symmetry Olsen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785101540·

    BAUMER FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·April 22, 2015

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 18, 2021

    IMMULITE® 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024

    IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022

    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 27, 2012

    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