BEUDAMED
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    SYNTHES (USA) SPHERICAL WASHERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450137475·

    POWER 5000 GENERAL PURPOSE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMEDITECH IMMUTEST DRUG SCREEN OPIATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 2, 2019

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE·Product code IOR·March 15, 2011

    COULTER AC T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 22, 2008

    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