BEUDAMED
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    GUIDED MEASUREMENT CATHETER (GMC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COPAN VIRAL TRANSYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    K-ASSAY C1-INA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PANORAMA CENTRAL STATION

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

    GENESIS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 28, 2014

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·May 17, 2011

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    VARIABLE LOCK SCREW 4.75X35MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018

    MAESTRO TC CARPALHD 7X15MM STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWN·January 24, 2018

    MAESTRO TC CARPAL PLATE 9X37MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018

    VARIABLE LOCK SCREW 4.75X15MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018

    MAESTRO RAD W/BRG 7X15 7.5 RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·January 24, 2018

    MAESTRO RADIAL STEM 6.0X40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWJ·October 23, 2017

    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