BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO

    FDA 510(k)
    FDA Class 2 ·Neurology

    STARTOX DRUG OF ABUSE SCREENING TEST (4)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EHC500 DESKTOP PATIENT STATION, MODEL EHC500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAD-8

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 15, 2015

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    SONOMA CRX

    FDA Adverse Event
    Injury ·SONOMA ORTHOPEDIC PRODUCTS INC.·Product code HSB·April 30, 2013

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·September 16, 2014

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·May 2, 2011

    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