BEUDAMED
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    AIRCAST VENAFLOW ELITE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122162·KWire .035x4" (0.9x100mm)

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0197000·Compressor - Distractor Lever, MIS

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702274493·Elvarex 3/Thigh High/Slant, Open Toe, Knee Comf...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702429992·Elvarex 1/Thigh High/Slant-Closed Toe/Dotted Si...

    Schaerer Medical USA

    FDA UDI
    Schaerer Medical Usa, Inc.·00810101300837·CROSS ARM SUPPORT PAD 2"

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 15, 2024

    MODULITH SLK LITHOTRIPTER

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

    XPLAN 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    BENEVIEW MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014

    LONG 45 ENDOCUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 17, 2011

    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·June 8, 2016

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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