BEUDAMED
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    BLOOD PRESSURE MONITOR, MODEL MD200A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SW, Legal Labelling Install Disk, 5.1.9

    FDA UDI
    Accuray Incorporated·00811376030795·TomoTherapy Treatment System (H Series)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450204771·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450391402·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left

    MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRYKER XCEL ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

    HEALON DUET

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LZP·May 3, 2013

    MICROAIRE

    FDA Adverse Event
    Malfunction ·MICROAIRE SURGICAL INSTRUMENTS·Product code HWC·September 8, 2014

    LAMITRODE 88 LEAD, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·April 14, 2011

    T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

    NEONATAL PATIENT CIRCUIT KIT

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

    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